Data / Medical devices / United States / Philips North America LLC
Philips North America LLC: FDA-registered device maker in Cambridge, MA, United States, 97 510(k) clearances
Philips North America LLC is registered with the FDA (registration 3016618143) in Cambridge, MA, United States. It lists 60 device types. The FDA files 97 510(k) clearances under its listings, the newest dated February 6, 2026. 77 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016618143
- Address
- 222 Jacobs Street, Cambridge, MA, United States, 02141
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| February 6, 2026 | K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) | MHX | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH | accessdata.fda.gov |
| November 10, 2025 | K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | MHX | Substantially Equivalent | Philips Medizin Systeme Böblingen GmbH | accessdata.fda.gov |
| October 17, 2025 | K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | MHX | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH | accessdata.fda.gov |
| March 4, 2022 | K211900 | Patient Information Center iX | MHX | Substantially Equivalent | Philips Medizin Systeme Böblingen GmbH | accessdata.fda.gov |
| September 30, 2021 | K212227 | Philips MR Patient Care Portal | MWI | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| June 30, 2021 | K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph | DPS | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| May 4, 2020 | K193228 | Hamilton-G5 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| April 16, 2020 | K192875 | Philips Biosensor BX100 | DRG | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| August 6, 2019 | K183387 | M3290B Patient Information Center iX | MHX | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| August 2, 2019 | K181216 | HAMILTON-T1, HAMILTON-C1 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| March 22, 2019 | K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| March 19, 2019 | K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | CBK | Substantially Equivalent | Maquet Critical Care AB | accessdata.fda.gov |
| February 8, 2019 | K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | 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 |
| August 2, 2017 | K162832 | 731 Series Ventilators | CBK | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| July 27, 2017 | K171423 | Nasal Alar SpO2 Sensor | DQA | Substantially Equivalent | Xhale, Inc. | accessdata.fda.gov |
| July 7, 2017 | K163584 | M3290B Philips IntelliVue Information Center iX | MHX | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| March 31, 2017 | K163649 | SureSigns VS3; SureSigns VS4 | DSJ | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| December 14, 2016 | K162343 | Westmed Gas Sampling Cannula with O2 delivery | CCK | Substantially Equivalent | Westmed, 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 |
| June 13, 2016 | K153702 | M3290B Philips IntelliVue Information Center iX | MHX | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| March 10, 2016 | K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines | CCK | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| December 23, 2015 | K152330 | Expression MR400 MRI Patient Monitoring System | MWI | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| October 30, 2015 | K151366 | Philips CS770 IntelliSpace Critical Care and Anesthesia | DXJ | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| October 27, 2015 | K152363 | Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M | DXQ | 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 |
| January 15, 2015 | K142935 | CareEvent | MSX | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| December 3, 2014 | K143057 | M3290B Philips IntelliVue Information Center iX | MSX | Substantially Equivalent | Philips Medical Systems | 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 |
| June 20, 2014 | K123149 | SERVO-I VENTILATOR SYSTEM | CBK | Substantially Equivalent | Maquet Critical Care AB | accessdata.fda.gov |
| August 12, 2013 | K131032 | PHILIPS SURESIGNS CENTRAL | MHX | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| July 15, 2013 | K131382 | EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL | MWI | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| April 18, 2013 | K123900 | SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 | MHX | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| April 12, 2013 | K122223 | NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO | BZQ | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH | accessdata.fda.gov |
| February 22, 2013 | K124061 | MRI PATIENT MONITORING SYSTEM (MODEL 865214) | MWI | Substantially Equivalent | Invivo Corporation | 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 |
| June 13, 2012 | K121424 | EXPRESSION INFORMATION PORTAL | MWI | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| November 17, 2011 | K113125 | INTELLIVUE MX40 PATIENT MONITOR | DSI | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| October 11, 2011 | K112652 | SURESIGNS VS2+ -SURESIGNS VSI | DXN | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| June 2, 2011 | K103578 | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST | BZK | Substantially Equivalent | Respironics Novametrix, LLC | accessdata.fda.gov |
| February 15, 2011 | K110287 | PHILIPS ECG LEADWIRE SET | DSA | 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 |
| September 30, 2010 | K102495 | M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 | MHX | Substantially Equivalent | Philips 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 |
| March 4, 2010 | K093388 | SMART CAPNOLINE GUARDIAN | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| December 18, 2009 | K093177 | INTELLIBRIDGE SYSTEM | MWI | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| December 15, 2009 | K090785 | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 | MWI | Substantially Equivalent | Invivo Corp. | accessdata.fda.gov |
| August 21, 2009 | K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES | DRX | Substantially Equivalent | Leonhard Lang GmbH | accessdata.fda.gov |
| August 21, 2009 | K092217 | MERCURY VCO2 | BZK | Substantially Equivalent | Respironics Novametrix, Inc. | accessdata.fda.gov |
| July 28, 2009 | K091459 | PHILIPS NM3 MONITOR, MODEL 7900 | BZK | Substantially Equivalent | Respironics Novametrix, LLC | accessdata.fda.gov |
| March 23, 2009 | K083750 | CAPNOSTAT / CAPNOFLEX CO2 SYSTEM | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
| December 18, 2008 | K083413 | COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM | BSZ | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| October 8, 2008 | K082280 | SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR | MHX | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
| August 22, 2008 | K081983 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 | MHX | Substantially Equivalent | Philips Medical Systems | 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 |
| March 20, 2007 | K070588 | PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER) | MHX | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| September 19, 2006 | K061573 | TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT | DRS | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 12, 2006 | K053174 | LOFLO C5 CO2 SENSOR | CCK | Substantially Equivalent | Respironics Novametrix, LLC | accessdata.fda.gov |
| November 19, 2004 | K042601 | CAPNOSTAT 5 | CCK | Substantially Equivalent | Respironics Novametrix, Inc. | accessdata.fda.gov |
| July 21, 2004 | K041741 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN | MHX | Substantially Equivalent | Philips Medical Systems, Inc. | accessdata.fda.gov |
| February 24, 2004 | K040249 | SKINTACT ECG ELECTRODE | DRX | Substantially Equivalent | Leonhard Lang GmbH | accessdata.fda.gov |
| January 27, 2004 | K040044 | HEEL SNUGGLER, MODEL 99047 | MPO | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 4, 2003 | K031124 | POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR | MHX | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| November 21, 2003 | K033444 | PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER | MHX | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| September 17, 2003 | K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 | HGP | Substantially Equivalent | Clinical Innovations, Inc. | accessdata.fda.gov |
| February 24, 2003 | K023931 | PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A | HGM | Substantially Equivalent | Philips Medical Systems, Inc. | 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 |
| November 14, 2001 | K011536 | MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| September 28, 2001 | K010949 | 2010 PLUS HOLTER FOR WINDOWS | MLO | Substantially Equivalent | Agilent Technologies | accessdata.fda.gov |
| May 4, 2001 | K011050 | MICROSTREAM ORAL NASAL CANNULA FILTERLINE | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| March 19, 2001 | K010052 | RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER | MQM | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| March 14, 2001 | K010024 | O2/CO2 NASAL FILTERLINE | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| September 21, 2000 | K002004 | ZYBIT | DXH | Substantially Equivalent | Zymed Medical Instrumentation | 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 |
| February 3, 2000 | K993383 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B | DSI | Substantially Equivalent | Hewlett-Packard GmbH | accessdata.fda.gov |
| April 16, 1998 | K980327 | MICROSTREAM FILTERLINE ICU | CCK | Substantially Equivalent | Oridion Medical , Ltd. | accessdata.fda.gov |
| April 16, 1998 | K980325 | MICROSTREAM NASAL CANNULA FILTERLINE | CCK | Substantially Equivalent | Oridion Medical , Ltd. | accessdata.fda.gov |
| April 16, 1998 | K980324 | MICROSTREAM FILLERLINE OR/EMS | CCK | Substantially Equivalent | Oridion Medical , Ltd. | 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 23, 1992 | K921561 | YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES | EZL | Substantially Equivalent | Ysis, Inc. | 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.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 21, 2026 | 99769 | Class II | Ongoing | Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. | accessdata.fda.gov |
| August 18, 2026 | 99865 | Class II | Ongoing | Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333 | The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation. | accessdata.fda.gov |
| August 7, 2026 | 99784 | Class II | Ongoing | Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311. | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. | accessdata.fda.gov |
| July 1, 2026 | 99361 | Class II | Ongoing | Cardiac Workstation 5000. Product Number: 860439. | Device will intermittently provide inaccurate data related to native heart rate. | accessdata.fda.gov |
| June 5, 2026 | 99126 | Class II | Ongoing | Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX. | Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system. | accessdata.fda.gov |
| May 26, 2026 | 99084 | Class II | Ongoing | Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output. | accessdata.fda.gov |
| May 1, 2026 | 98940 | Class II | Ongoing | DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. | System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events. | accessdata.fda.gov |
| January 7, 2026 | 98248 | Class II | Ongoing | Brilliance iCT; Product Code (REF): 728306 | As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed ev | accessdata.fda.gov |
| December 12, 2025 | 98158 | Class II | Ongoing | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. | It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly. | accessdata.fda.gov |
| October 31, 2025 | 97917 | Class II | Ongoing | IntelliVue MP2. Product Number: M8102A. | Potential issue where the IntelliVue monitors did not alarm. | accessdata.fda.gov |
| October 29, 2025 | 97919 | Class II | Ongoing | Incisive CT; Software Version Number: 4.5, 5.0, 5.1 | If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger. | accessdata.fda.gov |
| August 13, 2025 | 97468 | Class II | Ongoing | Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317 | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. | accessdata.fda.gov |
| May 29, 2025 | 97010 | Class II | Ongoing | Spectral CT. Computed tomography X-ray system. | Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance. | accessdata.fda.gov |
| May 13, 2025 | 96889 | Class II | Ongoing | Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146 | Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. | accessdata.fda.gov |
| April 7, 2025 | 96677 | Class II | Ongoing | Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm, Adt/Pedi Intub CO2 Line STerm Lng, Adt/Pedi Intub CO2 Line High Humidity, Adt/Pedi Intub CO2 Line LTerm Lng, Adt/Pe | Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible. | accessdata.fda.gov |
| April 1, 2025 | 96667 | Class II | Ongoing | Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System. | Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient. | accessdata.fda.gov |
| March 10, 2025 | 96435 | Class II | Ongoing | Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. | Potential for collimator to fall as a result of incorrect installation. | accessdata.fda.gov |
| February 25, 2025 | 96593 | Class II | Ongoing | Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within t | A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation. | accessdata.fda.gov |
| January 15, 2025 | 96138 | Class II | Ongoing | IntelliBridge EC10 Module. Model Number: 865115 | Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board. | accessdata.fda.gov |
| November 20, 2024 | 95847 | Class II | Ongoing | Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216 | The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially causing the client device to appear to drop out from the network. 2. if the Access Point experiences a disconnection from the Access Point Controller exceeding 4 minutes, the A | accessdata.fda.gov |
| November 16, 2024 | 95810 | Class II | Ongoing | Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344. | Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis. | accessdata.fda.gov |
| November 4, 2024 | 95645 | Class II | Ongoing | Achieva TX Interventional Coil 3.0T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | accessdata.fda.gov |
| September 3, 2024 | 95289 | Class II | Ongoing | Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated | accessdata.fda.gov |
| June 28, 2024 | 94919 | Class II | Ongoing | IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, mult | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patien | accessdata.fda.gov |
| June 5, 2024 | 94786 | Class I | Ongoing | SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 9 | Potential for coils to heat up and harm patients (burn). | accessdata.fda.gov |
| May 22, 2024 | 94774 | Class II | Ongoing | Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate. | Potential for inaccurate fetal heart rate measurements when monitoring multiples. | accessdata.fda.gov |
| May 3, 2024 | 94603 | Class II | Ongoing | HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411 | Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard | accessdata.fda.gov |
| May 3, 2024 | 94508 | Class II | Ongoing | Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire | accessdata.fda.gov |
| April 22, 2024 | 94493 | Class II | Ongoing | Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116 | Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation | accessdata.fda.gov |
| April 19, 2024 | 94468 | Class II | Ongoing | Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x. | Event Catalog information does not save when copied and transferred from one unit to another. | accessdata.fda.gov |
| April 15, 2024 | 94536 | Class II | Ongoing | Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143 | Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity | accessdata.fda.gov |
| March 29, 2024 | 94352 | Class II | Ongoing | The Oncology Essentials Package of the Spectral CT imaging system. | Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment. | accessdata.fda.gov |
| March 22, 2024 | 94340 | Class II | Ongoing | Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider Electric IT Corporation) 23 | Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power. may lead to the delay in the detection of a change in a patient condition | accessdata.fda.gov |
| March 12, 2024 | 94233 | Class II | Ongoing | Achieva 1.5T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | accessdata.fda.gov |
| February 15, 2024 | 95316 | Class II | Ongoing | DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126 | If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a patient condition which prompted the alarm to generate. Although unlikely, this could potentially result in a patient harm. | accessdata.fda.gov |
| November 30, 2023 | 93640 | Class II | Ongoing | Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. | Multiple software issues that affect device functionality. | accessdata.fda.gov |
| November 17, 2023 | 93454 | Class I | Ongoing | Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device. | Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain the pressured helium gas due to an unforeseen blockage in the system, risks to patients and/or operators that may lead to injury or death inclu | accessdata.fda.gov |
| October 23, 2023 | 93361 | Class II | Ongoing | Achieva 1.5T | Potential component failure in the Gradient Coil could product smoke and/or fire. | accessdata.fda.gov |
| October 9, 2023 | 93291 | Class II | Ongoing | Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy. | For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible gro | accessdata.fda.gov |
| September 21, 2023 | 93200 | Class II | Ongoing | CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system | Potential for units suspended on the ceiling to fail and fall. | accessdata.fda.gov |
| August 31, 2023 | 93020 | Class II | Ongoing | EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380 | A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated. | accessdata.fda.gov |
| August 17, 2023 | 92992 | Class II | Ongoing | Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essen | Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central patient monitoring. Potential for a delay in the detection of a change or deterioration in the condition of one or more patients | accessdata.fda.gov |
| June 14, 2023 | 95324 | Class II | Ongoing | IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) | Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively r | accessdata.fda.gov |
| May 19, 2023 | 92462 | Class II | Ongoing | DigitalDiagnost C90, Model No. 712034 and 712035 | There is a software login in issue that may prevent the user from logging in. | accessdata.fda.gov |
| March 17, 2023 | 92064 | Class II | Ongoing | Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333 | Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation. | accessdata.fda.gov |
| March 9, 2023 | 91915 | Class II | Ongoing | Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201 | If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently i | accessdata.fda.gov |
| March 6, 2023 | 92063 | Class II | Ongoing | EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359 | EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition. | accessdata.fda.gov |
| November 22, 2022 | 91195 | Class II | Ongoing | Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | accessdata.fda.gov |
| November 21, 2022 | 91220 | Class II | Ongoing | Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631 | Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product. | accessdata.fda.gov |
| October 21, 2022 | 91979 | Class II | Ongoing | Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system | Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and damage the cable. If the tabletop cable breaks, the user may not be able to initiate table tilting movements or braking | accessdata.fda.gov |
| September 6, 2022 | 90857 | Class II | Ongoing | MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162. | Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue. | accessdata.fda.gov |
| March 29, 2022 | 93509 | Class II | Completed | The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal | Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use. | accessdata.fda.gov |
| February 25, 2022 | 90728 | Class II | Ongoing | DigitalDiagnost C50 1.1 | Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection | accessdata.fda.gov |
| February 22, 2022 | 89878 | Class II | Terminated | Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic System. | When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure applied will be higher than 150 mmHg and the deflation pressure will be higher than 5 mmHg. An applied cuff inflation pressure higher than 150mm | accessdata.fda.gov |
| February 2, 2022 | 89787 | Class II | Ongoing | Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722 | Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient. | accessdata.fda.gov |
| January 3, 2022 | 89489 | Class II | Terminated | eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical | eCareManager (eCM) Sentry Score software not approved for use | accessdata.fda.gov |
| November 29, 2021 | 89163 | Class II | Ongoing | Infant Heel Warmers w/strap, Reference # 989805603201 1223 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance. | accessdata.fda.gov |
| November 26, 2021 | 89173 | Class II | Ongoing | Infa-Therm Transport Mattress, Reference Number 989805616831 1015 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance. | accessdata.fda.gov |
| November 24, 2021 | 89375 | Class II | Ongoing | Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 7220 | 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 |
| November 19, 2021 | 89203 | Class II | Terminated | Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Mod | Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention. | accessdata.fda.gov |
| November 12, 2021 | 89174 | Class II | Terminated | Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, | (1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available | accessdata.fda.gov |
| November 12, 2021 | 89129 | Class II | Ongoing | BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075 | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns | accessdata.fda.gov |
| October 29, 2021 | 89044 | Class II | Ongoing | Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System. Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, | Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure | accessdata.fda.gov |
| October 21, 2021 | 91853 | Class II | Ongoing | CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031 | If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet. | accessdata.fda.gov |
| September 24, 2021 | 88854 | Class II | Terminated | Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M | When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable. | accessdata.fda.gov |
| August 13, 2021 | 88546 | Class II | Terminated | The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This incl | 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 generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be n | accessdata.fda.gov |
| August 11, 2021 | 88491 | Class II | Completed | Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the interna | When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment | accessdata.fda.gov |
| July 30, 2021 | 88461 | Class II | Terminated | Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury | accessdata.fda.gov |
| June 8, 2021 | 88336 | Class II | Terminated | 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient. | accessdata.fda.gov |
| May 1, 2021 | 89039 | Class II | Ongoing | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-t | Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part | accessdata.fda.gov |
| May 1, 2021 | 87974 | Class II | Ongoing | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201 | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury. | accessdata.fda.gov |
| April 23, 2021 | 87962 | Class II | Ongoing | Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X | The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet. | accessdata.fda.gov |
| April 13, 2021 | 87872 | Class II | Terminated | BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306 | Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury | accessdata.fda.gov |
| March 29, 2021 | 87732 | Class II | Ongoing | Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated wit | Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient weight is rounded to the nearest whole kilogram;Xper IM software used with the Xper Flex Cardio Physio Monitoring System may periodically crash; No SpO2 numeric or plethysm | accessdata.fda.gov |
| February 22, 2021 | 87427 | Class II | Terminated | Incisive CT Computed Tomography X-ray System Model: 728143 | Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees | accessdata.fda.gov |
| February 2, 2021 | 87829 | Class II | Terminated | IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parame | Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices | accessdata.fda.gov |
| November 18, 2020 | 86848 | Class II | Terminated | Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates | Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient. | accessdata.fda.gov |
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Updated September 18, 2026. 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.