Data / Medical devices / United States / Philips North America LLC
Philips North America LLC: FDA-registered device maker in Andover, MA, United States, 38 510(k) clearances
Philips North America LLC is registered with the FDA (registration 1218950) in Andover, MA, United States. It lists 39 device types. The FDA files 38 510(k) clearances under its listings, the newest dated August 6, 2019. 267 recall events name it as the recalling firm (3 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1218950
- Address
- 3000 Minuteman Rd, Andover, MA, United States, 01810
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 13, 1992
- Registered through
- 2026
- Brand names listed
- 1037632 Bilichek (Advanced), 13943B Solid Gel Tab Electrode, Resting ECG, 13951C Neonatal/Pediatric Solid Gel Electrode, 13952A Preattached Leadwire Electrode medium, 13952B Preattached Leadwire electrode medium, 13952D Metallic Preattached Leadwire Electrode, Medium, 13953A Preattached Leadwire electrode square, 13953B Preattached leadwire electrode square and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 6, 2019 | K183387 | M3290B Patient Information Center iX | MHX | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| July 24, 2018 | K180017 | MX40 Release C.01 | MHX | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| November 9, 2017 | K172226 | MX40 Release B.07 | MHX | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| July 27, 2017 | K171423 | Nasal Alar SpO2 Sensor | DQA | Substantially Equivalent | Xhale, Inc. | accessdata.fda.gov |
| June 24, 2016 | K161164 | CareEvent inclusive of the CareEvent Mobile Application accessory | MSX | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| October 30, 2015 | K151366 | Philips CS770 IntelliSpace Critical Care and Anesthesia | DXJ | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| September 29, 2015 | K151761 | SureSigns VS3, SureSigns VS4 | DSJ | Substantially Equivalent | Phillips Medical Systems | accessdata.fda.gov |
| December 3, 2014 | K143057 | M3290B Philips IntelliVue Information Center iX | MSX | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| November 25, 2014 | K140535 | PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 | HGM | Substantially Equivalent | Philips Medizin Systeme Boblingen GmbH | accessdata.fda.gov |
| August 27, 2014 | K140862 | MONICA NOVII WIRELESS PATCH SYSTEM | OSP | Substantially Equivalent | Monica Healthcare, Ltd. | accessdata.fda.gov |
| June 26, 2014 | K133961 | SURESIGNS VS3, SURESIGNS VS4 | DSJ | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| July 18, 2012 | K121638 | ST80I STRESS TEST SYSTEM | DQK | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| June 29, 2012 | K120855 | INTELLISPACE ECG | DQK | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| November 17, 2011 | K113125 | INTELLIVUE MX40 PATIENT MONITOR | DSI | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| January 7, 2011 | K103646 | INTELLIVUE MX40 PATIENT MONITOR | MHX | Substantially Equivalent | Phillips Medical Systems | accessdata.fda.gov |
| August 31, 2010 | K101600 | INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL | DQA | Substantially Equivalent | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | accessdata.fda.gov |
| July 29, 2010 | K101521 | ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O | MHX | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| August 21, 2009 | K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES | DRX | Substantially Equivalent | Leonhard Lang GmbH | accessdata.fda.gov |
| May 9, 2008 | K080999 | PAGEWRITER CARDIOGRAPH | DPS | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| February 1, 2008 | K080106 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE | DRX | Substantially Equivalent | Leonhard Lang GmbH | accessdata.fda.gov |
| December 20, 2007 | K071885 | ANTIMICROBIAL AND SINGLE-PATIENT CUFFS | OED | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| July 24, 2007 | K071733 | DL900 SERIES HOLTER RECORDER | MWJ | Substantially Equivalent | Braemar, Inc. | accessdata.fda.gov |
| February 24, 2004 | K040249 | SKINTACT ECG ELECTRODE | DRX | Substantially Equivalent | Leonhard Lang GmbH | accessdata.fda.gov |
| January 16, 2003 | K024247 | SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL | DRX | Substantially Equivalent | Leonhard Lang GmbH | accessdata.fda.gov |
| November 14, 2002 | K023503 | SKINTACT ECG ELECTRODE | DRX | Substantially Equivalent | Leonhard Lang GmbH | accessdata.fda.gov |
| January 3, 2002 | K011564 | NEOLEAD | DRX | Substantially Equivalent | Neotech Products, Inc. | accessdata.fda.gov |
| September 28, 2001 | K010949 | 2010 PLUS HOLTER FOR WINDOWS | MLO | Substantially Equivalent | Agilent Technologies | accessdata.fda.gov |
| March 19, 2001 | K010052 | RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER | MQM | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| May 17, 2000 | K001333 | AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI | DSI | Substantially Equivalent | Agilent Technologies Deutschland GmbH | accessdata.fda.gov |
| December 3, 1997 | K973437 | HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES | DPS | Substantially Equivalent | Hewlett-Packard GmbH | accessdata.fda.gov |
| July 19, 1996 | K962070 | YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE | FLL | Substantially Equivalent | Yellow Springs Instrument Co., Inc. | accessdata.fda.gov |
| June 21, 1996 | K953649 | DISPOSABLE ECG ELECTRODE | DRX | Substantially Equivalent | Kendall-Ltp | accessdata.fda.gov |
| November 7, 1991 | K913533 | MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) | DXH | Substantially Equivalent | Hewlett-Packard Co. | accessdata.fda.gov |
| December 20, 1990 | K905101 | NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF | DXQ | Substantially Equivalent | Hewlett-Packard Co. | accessdata.fda.gov |
| October 31, 1990 | K904185 | SENSATRACE | DRX | Substantially Equivalent | Ludlow Corp., Technical Papers Division | accessdata.fda.gov |
| July 31, 1990 | K900682 | PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE | DRY | Substantially Equivalent | Contour Electrodes, Inc. | accessdata.fda.gov |
| May 12, 1987 | K871412 | CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO | DRX | Substantially Equivalent | Contour Electrodes, Inc. | accessdata.fda.gov |
| April 3, 1979 | K790305 | ELECTRODES, FERRIS ECG, TYPES 905,906 | DRX | Substantially Equivalent | Ferris Mfg. Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 267.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 7, 2022 | 89791 | Class II | Ongoing | The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641. | Update to instructions for use regarding the cleaning and disinfection process for the reusable probes. | accessdata.fda.gov |
| February 2, 2022 | 89750 | Class II | Terminated | Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x | Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system, the following on-screen message is displayed to the user in the Philips StentBoost Live application: "Press the cine pedal until the acquisiti | accessdata.fda.gov |
| September 24, 2021 | 89020 | Class II | Ongoing | Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) | 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or landscape orientation with an angle of 0 or +/-90 d | accessdata.fda.gov |
| September 22, 2021 | 89023 | Class II | Ongoing | DigitalDiagnost C90 | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these la | accessdata.fda.gov |
| May 26, 2021 | 89742 | Class II | Completed | Azurion systems with software release R2.0.x | In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure, the Patient Type changes inadvertently to a Patient Type different than t | accessdata.fda.gov |
| March 23, 2021 | 87418 | Class II | Terminated | Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only | Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the input signal rate is over 300 bpm, the indicated rate of the affected products will be lower than this upper limit | accessdata.fda.gov |
| November 19, 2020 | 86901 | Class II | Terminated | Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. | A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient. | accessdata.fda.gov |
| September 14, 2020 | 86441 | Class II | Terminated | Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator | The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that includes a test for the switched paddles only, which will detect this failure mode. | accessdata.fda.gov |
| July 16, 2020 | 85743 | Class II | Terminated | Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital a | The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user. These device behaviors could result in a delay in the | accessdata.fda.gov |
| June 30, 2020 | 85908 | Class II | Terminated | IntelliVue MX800 patient monitor, model no. 865240 | Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not followed, and may also cause the monitor to stop operating or prevent it from being switched on. | accessdata.fda.gov |
| June 25, 2020 | 85795 | Class II | Ongoing | IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173 | The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and generating one or more technical or INOP alarms. | accessdata.fda.gov |
| June 18, 2020 | 86025 | Class II | Terminated | Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for pati | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger. | accessdata.fda.gov |
| June 8, 2020 | 85799 | Class II | Terminated | Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036) | Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and lntelliVue MMX multi-measurement server (Model No. 867036).If they are connected to a host monitor, communication with the X3 or MMX could be disrupted, resulting in a loss of monitoring on the host monitor. | accessdata.fda.gov |
| June 2, 2020 | 85810 | Class II | Terminated | EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose. | Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction. | accessdata.fda.gov |
| May 19, 2020 | 85729 | Class II | Terminated | Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intui | Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that was not intended for commercial distribution and for which Philips does not have records regarding its manufacture. Philips is therefore removing this device from distribution. | accessdata.fda.gov |
| April 27, 2020 | 85588 | Class II | Terminated | Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation. | HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections | accessdata.fda.gov |
| April 23, 2020 | 85603 | Class II | Terminated | ProxiDiagnost N90, UDI 706100 | The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution Unit, may be incorrectly installed and not working. If the transformer overheats due to a first failure and the thermo switch is not activated, the device may begin to generate smoke. | accessdata.fda.gov |
| April 21, 2020 | 85580 | Class II | Terminated | Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life | HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections | accessdata.fda.gov |
| April 20, 2020 | 85571 | Class II | Terminated | Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - Produc | Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine operational checks are followed. The instructions for use rely on these checks rather than specifying a maximum number of sterilization cycles to determine when the paddles should be discarded. A damaged Interna | accessdata.fda.gov |
| April 13, 2020 | 85560 | Class II | Terminated | Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting | The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex. | accessdata.fda.gov |
| April 13, 2020 | 85147 | Class II | Terminated | Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life | The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed. | accessdata.fda.gov |
| April 10, 2020 | 85473 | Class II | Terminated | Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth | When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V) and/or the video signal can be lost. | accessdata.fda.gov |
| April 10, 2020 | 85462 | Class II | Terminated | HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified me | Damaged ESD bags used for storing components in Processor PCA Replacement Kits | accessdata.fda.gov |
| April 7, 2020 | 85472 | Class II | Terminated | Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography. | If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury. | accessdata.fda.gov |
| April 6, 2020 | 85513 | Class II | Terminated | Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848 | The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems. | accessdata.fda.gov |
| April 3, 2020 | 85399 | Class II | Terminated | Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079 | When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning message directs the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use | accessdata.fda.gov |
| March 5, 2020 | 85241 | Class II | Terminated | TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861 | The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a Philips Patient Information Center iX Release C.02.xx or C.03.01. If this occurs, the Information Center will not display a heart rate or generate, display or annunciate any heart rate or arrhythmia alar | accessdata.fda.gov |
| March 5, 2020 | 85205 | Class II | Terminated | Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, c | No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becoming loose.. | accessdata.fda.gov |
| February 26, 2020 | 84841 | Class II | Terminated | HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9. | Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a severe mechanical shock, even though the device did not have visible external damage or the Ready for Use ( RFU ) indicator on the unit did not immediately indica | accessdata.fda.gov |
| February 20, 2020 | 85090 | Class II | Terminated | Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitoring Systems is intend | Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing the O2 sensor calibration are incorrect for customers performing this task with an MR400 device with software revisions: 01.03.00, 01.04.00, 01.05.00 and 01.07.00 | accessdata.fda.gov |
| January 14, 2020 | 84796 | Class II | Terminated | Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments. | M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments | accessdata.fda.gov |
| January 13, 2020 | 84879 | Class II | Terminated | Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: - 453564067151 | if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display Error: 602 and fail to function for a new patient study. | accessdata.fda.gov |
| December 30, 2019 | 84756 | Class II | Terminated | Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator. | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible. | accessdata.fda.gov |
| December 23, 2019 | 84708 | Class II | Terminated | VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azur | Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction. | accessdata.fda.gov |
| November 20, 2019 | 86416 | Class II | Terminated | ProxiDiagnost N90 | Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose. | accessdata.fda.gov |
| October 16, 2019 | 84115 | Class II | Terminated | HeartStart XL+ Defibrillator/Monitor, Model 861290 | The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user. | accessdata.fda.gov |
| October 3, 2019 | 84236 | Class II | Terminated | HeartStart XL+ Defibrillator/Monitor, Model 861290 | Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device will indicate that it is not ready for use. | accessdata.fda.gov |
| August 23, 2019 | 83679 | Class II | Terminated | IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (PN | Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations | accessdata.fda.gov |
| July 19, 2019 | 83560 | Class II | Terminated | Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration | The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements. | accessdata.fda.gov |
| July 16, 2019 | 83576 | Class II | Terminated | HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automati | Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices. | accessdata.fda.gov |
| July 16, 2019 | 83477 | Class II | Terminated | Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 72 | The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment. | accessdata.fda.gov |
| June 7, 2019 | 82750 | Class II | Terminated | Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 | The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery. | accessdata.fda.gov |
| April 29, 2019 | 82914 | Class III | Terminated | Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade | Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX using a LAN driver may be recorded in the patients chart or electronic medical record at exactly 100 times the actual bolus rate, infusion rate and total volume values | accessdata.fda.gov |
| April 19, 2019 | 82684 | Class II | Ongoing | SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. | accessdata.fda.gov |
| March 28, 2019 | 82696 | Class II | Ongoing | IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Ce | The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State. | accessdata.fda.gov |
| March 12, 2019 | 82469 | Class II | Terminated | Azurion FlexArm, 722079 | During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector. | accessdata.fda.gov |
| February 28, 2019 | 82313 | Class II | Terminated | MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more special | The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user. | accessdata.fda.gov |
| January 25, 2019 | 82422 | Class II | Terminated | Fetal Spiral Electrode, Model No. 9898 031 37631 | During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery. | accessdata.fda.gov |
| January 25, 2019 | 82264 | Class II | Terminated | Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological paramet | Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor | accessdata.fda.gov |
| January 9, 2019 | 81957 | Class II | Ongoing | PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users. | accessdata.fda.gov |
| December 21, 2018 | 83654 | Class II | Terminated | DigitalDiagnost C50, Stationary X-ray System | During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing label. This notification is intended to provide you with information regarding what the issue is, and relevant affected product, the actions you are required to take and the actions planned by Philips to correct the issue. If you need any or further information | accessdata.fda.gov |
| November 15, 2018 | 81527 | Class II | Terminated | Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081 | There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze. 3) In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device w | accessdata.fda.gov |
| October 10, 2018 | 81531 | Class II | Ongoing | IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. | A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when operating in Monitor Mode. These devices may intermittently exhibit Speaker Malfunct INOP messages after the Power On Self-T | accessdata.fda.gov |
| July 16, 2018 | 80922 | Class II | Terminated | INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander. | accessdata.fda.gov |
| July 13, 2018 | 80645 | Class II | Ongoing | Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric an | Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on ei | accessdata.fda.gov |
| June 11, 2018 | 80402 | Class II | Terminated | Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interv | The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination. | accessdata.fda.gov |
| May 3, 2018 | 79982 | Class II | Terminated | HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular ta | The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could potentially cause therapy to be interrupted or delayed. | accessdata.fda.gov |
| April 30, 2018 | 80064 | Class II | Terminated | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350 | Five warning statements are missing from the instructions for use. | accessdata.fda.gov |
| March 16, 2018 | 79451 | Class II | Terminated | Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multiva 1.5T Model 781076, & 5) Multiva 1.5T 16ch R5 based Model 781078 Product Usage: | Potential risk for helium gas inside the MR examination room during a magnet quench | accessdata.fda.gov |
| March 14, 2018 | 79770 | Class II | Terminated | Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Va | After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself. | accessdata.fda.gov |
| February 7, 2018 | 79191 | Class III | Terminated | HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, adv | Update XL device software to version A.03. This includes enhancements to the Operational Checks, event logs, and troubleshooting messages that provide as complete of information as needed to users on device readiness. | accessdata.fda.gov |
| January 29, 2018 | 79016 | Class II | Terminated | Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devic | Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent Injunction No. 1:17-cv-11955-DJC, entered October 31, 2017 between United States of America and Philips North America | accessdata.fda.gov |
| January 4, 2018 | 79099 | Class II | Terminated | Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and ne | There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these products. Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may | accessdata.fda.gov |
| January 3, 2018 | 79132 | Class II | Terminated | Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info C | Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable to perform patient discharge and transfer operations. Any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the Surveillance station during such restart. Until this issue can be | accessdata.fda.gov |
| December 20, 2017 | 79091 | Class II | Terminated | Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interv | Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. The two small set screws securing the two gliding rods into an aluminum block of the support arm can come loose because of vibrations and forces exerted on them. If the set screws have come loose gravity can keep the rods | accessdata.fda.gov |
| December 11, 2017 | 79139 | Class II | Terminated | digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radio | It the WiFi connection between the SkyPlate detector and HP transfer point is weak, an image may fail to transfer from the SkyPlate detector to the system. The image remains in the memory of the detector, but cannot be transferred wirelessly or by use of the backup cable. To continue, the operator can reset the SkyPlate detector by removing its batteries, bu | accessdata.fda.gov |
| November 17, 2017 | 78732 | Class II | Terminated | IntelliVue X3 Patient Monitor. | The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to wrong internal NBP setting. Furthermore, occasionally the Monitor shows the Check Touch Input message and the monitor is inoperable with the | accessdata.fda.gov |
| October 19, 2017 | 78880 | Class II | Terminated | CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like | The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified distance. | accessdata.fda.gov |
| October 5, 2017 | 78849 | Class II | Terminated | Philips Network Firewall (Cisco ASA 5506), Model # 867098 | Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic may have a defective component, which may result in loss of connection to the Information Center iX. The defect involves the clock signal component within the firewall. This component has a high probability of failing in appliances that have been running for greate | accessdata.fda.gov |
| September 28, 2017 | 78698 | Class II | Terminated | Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator | Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram). | accessdata.fda.gov |
| September 20, 2017 | 78733 | Class III | Terminated | Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility. | Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM, instead of the specific date in the format of YYYY-MM. | accessdata.fda.gov |
| August 23, 2017 | 78736 | Class II | Ongoing | IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care profess | Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors | accessdata.fda.gov |
| August 18, 2017 | 78739 | Class II | Terminated | Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging appli | When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurements performed using the QA Basic Measurement tool will not be correctly exported to the external DICOM destination. | accessdata.fda.gov |
| July 17, 2017 | 78702 | Class II | Terminated | ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2 | Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs): " On the HeartStart MRx and HeartStart XL, EFT noise may be misinterpreted as an R | accessdata.fda.gov |
| July 14, 2017 | 78833 | Class II | Terminated | Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a gri | If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. This may happen when the detector is rotated clockwise from landscape to portrait position. | accessdata.fda.gov |
| July 12, 2017 | 78351 | Class I | Terminated | MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use | Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode. | accessdata.fda.gov |
| May 31, 2017 | 77410 | Class II | Terminated | Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211) | Tube arm assembly could fall down due to cracked welding joints | accessdata.fda.gov |
| May 11, 2017 | 77312 | Class II | Terminated | Philips DigitalDiagnost 3.1.x X-Ray System | During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions. | accessdata.fda.gov |
| May 4, 2017 | 77166 | Class II | Terminated | NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383) | Manufacturing defect may cause localized heating, which may result in localized skin burn. | accessdata.fda.gov |
| March 22, 2017 | 76810 | Class II | Terminated | Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 biplane 722029; Allura Xper FD10 OR Table 722033; Allura Xper FD10/10 OR Table 722034; | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire. | accessdata.fda.gov |
| March 6, 2017 | 76656 | Class II | Terminated | Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usa | Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audible alarms when association with central monitoring system is unsuccessful [incomplete] | accessdata.fda.gov |
| February 24, 2017 | 76545 | Class I | Terminated | HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 | HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring | accessdata.fda.gov |
| January 18, 2017 | 78144 | Class II | Terminated | Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dat | During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient. | accessdata.fda.gov |
| January 17, 2017 | 76274 | Class II | Terminated | Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from | The monitor may not alarm appropriately for a pediatric or neonatal patient. | accessdata.fda.gov |
| December 27, 2016 | 76079 | Class II | Terminated | Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center | May experience a loss of centralized monitoring. | accessdata.fda.gov |
| December 9, 2016 | 76080 | Class II | Terminated | Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane) | System may lock up. | accessdata.fda.gov |
| December 1, 2016 | 75845 | Class II | Terminated | Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations | Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled. | accessdata.fda.gov |
| December 1, 2016 | 75844 | Class II | Terminated | Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those pa | Possibility that a patient or user may be exposed to a very small level of touch current. | accessdata.fda.gov |
| September 19, 2016 | 75209 | Class II | Terminated | Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisio | Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX | accessdata.fda.gov |
| August 26, 2016 | 75041 | Class II | Terminated | HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A | The handle can separate from the MRx housing due to breakage of mounts on the rear case. | accessdata.fda.gov |
| August 12, 2016 | 74920 | Class II | Terminated | PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography). | A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing. | accessdata.fda.gov |
| July 26, 2016 | 74751 | Class II | Terminated | IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be | If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition. | accessdata.fda.gov |
| July 19, 2016 | 74731 | Class II | Terminated | MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038. | The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag | accessdata.fda.gov |
| July 7, 2016 | 74616 | Class II | Terminated | Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034 | Increase in the failure rate of certain low-voltage DC power supplies (DCPS) | accessdata.fda.gov |
| April 14, 2016 | 73825 | Class II | Terminated | HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operatio | MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. | accessdata.fda.gov |
| March 15, 2016 | 75551 | Class II | Terminated | Philips Healthcare System X-ray Tomography Computed : | It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure. | accessdata.fda.gov |
| February 10, 2016 | 73281 | Class II | Terminated | evaluemed Infant Heel Warmer; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur | eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification. | accessdata.fda.gov |
| January 8, 2016 | 73023 | Class II | Terminated | DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621 | In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation. | accessdata.fda.gov |
| January 4, 2016 | 73209 | Class II | Terminated | Philips IntelliVue Measurement Module X1 Model: M3001A | The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor | accessdata.fda.gov |
| November 25, 2015 | 72720 | Class II | Terminated | Philips Healthcare IntelliVue Info Center iX, A.0 866023 | Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. | accessdata.fda.gov |
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Updated August 6, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.