Data / Medical devices / United States / Philips North America LLC
Philips North America LLC: FDA-registered device maker in Bothell, WA, United States, 3 510(k) clearances and 3 PMA approvals
Philips North America LLC is registered with the FDA (registration 3030677) in Bothell, WA, United States. It lists 5 device types. The FDA files 3 510(k) clearances and 3 PMA approvals under its listings, the newest dated January 11, 2021. 100 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030677
- FEI number
- 1000524572
- Address
- 22100 Bothell Everett Hwy, Bothell, WA, United States, 98021
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Manufacturer, Specification developer
- First device listed
- August 24, 1999
- Registered through
- 2026
- Brand names listed
- 05-10000 - Heartstream Pads to QUIK-COMBO Adapter [FR2], 05-10100 - Heartstream Pads to Zoll Adapter, 68-PCHAT, Fast Respond Kit, 861304 HeartStart FRx Defibrillator, 989803139261 SMART Pads II, 989803139301 Aviation FRx Battery, 989803139311 Infant/Child Key, 989803149981 and 989803149991 SMART Pads III and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | 3 | Manufacturer, Specification developer | accessdata.fda.gov |
| Cable, Electrode | IKD | 2 | Specification developer | accessdata.fda.gov |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | 2 | Specification developer | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Specification developer | accessdata.fda.gov |
| Over-The-Counter Automated External Defibrillator | NSA | 3 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| January 11, 2021 | K203231 | Switched Internal Paddles | LDD | Substantially Equivalent | Philips North America, LLC | accessdata.fda.gov |
| December 17, 1998 | K984286 | HEARTSTREAM ELECTRODE ADAPTER | MKJ | Substantially Equivalent | Hewlett-Packard Co. | accessdata.fda.gov |
| September 25, 1997 | K972418 | HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX) | MKJ | Substantially Equivalent | Heartstream, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 11, 2020 | P180028 | HeartStart FRx Defibrillator | MKJ | 19 | May 21, 2026 | accessdata.fda.gov |
| May 11, 2020 | P160028 | Philips HeartStart FR3 Defibrillator | MKJ | 7 | May 21, 2026 | accessdata.fda.gov |
| June 6, 2019 | P160029 | HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) | NSA | 26 | February 2, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 4, 2022 | 89672 | Class II | Ongoing | Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS | There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. | accessdata.fda.gov |
| July 16, 2021 | 88361 | Class II | Terminated | Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator | Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient | accessdata.fda.gov |
| February 9, 2021 | 88637 | Class II | Ongoing | Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A | Customers were not notified of previous recalls associated with various defibrillator models. | accessdata.fda.gov |
| September 10, 2019 | 84850 | Class II | Terminated | Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017 | Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards. | accessdata.fda.gov |
| November 23, 2018 | 81443 | Class II | Terminated | HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators. | Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the Monitor/Defibrillator, which may prevent operation of the device if it is not connected to AC or DC power. Should a second, unaffected battery be present in the Monitor/Defibrillator, | accessdata.fda.gov |
| October 10, 2018 | 81134 | Class II | Terminated | Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and | Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur. | accessdata.fda.gov |
| August 8, 2018 | 83681 | Class II | Terminated | Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758 | The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child pad cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the Adult pads cartridge and may therefor | accessdata.fda.gov |
| March 14, 2018 | 79343 | Class II | Terminated | Philips HeartStart FRx AED. | An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed. | accessdata.fda.gov |
| February 28, 2014 | 67685 | Class II | Terminated | Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound | A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the veloci | accessdata.fda.gov |
| February 6, 2014 | 67622 | Class II | Terminated | Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained | Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. In the event the PCB becomes separated from the electrical contact points, the AED may not | accessdata.fda.gov |
| February 6, 2014 | 67612 | Class II | Terminated | Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when | Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be | accessdata.fda.gov |
| October 17, 2013 | 66662 | Class II | Terminated | EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis. | A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established Due Date (EDD). | accessdata.fda.gov |
| July 26, 2012 | 63030 | Class II | Terminated | Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrill | Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there | accessdata.fda.gov |
| June 1, 2011 | 58993 | Not yet classified | Terminated | The SIU (System Interface Unit) is a component in the Tool Connection Unit of the PercuNav system. It is part of the position sensor system used to calculate the position of the instrument. The Tool Connection Unit is a | PercuNav Tool Connection Unit may contain an electronic component that does not meet specification, which could cause registration difficulties and/or inaccurate instrument tracking. | accessdata.fda.gov |
| April 1, 2011 | 58429 | Not yet classified | Terminated | PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911. Designed to be used only with the PercuNav" image guided intervention system. The Field Generator Stand (with articulating | The PercuNav Field Generator Stand could tip over during set up, during use, or during transport. | accessdata.fda.gov |
| December 14, 2010 | 57611 | Not yet classified | Terminated | Philips BV Libra, Mobile X-ray unit, 718022. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety surgical and non-surgical applications including; cerebral, thoracic, abdominal, | The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a procedure when used with the BV Libra and the BV Pulsera/Endura Systems. | accessdata.fda.gov |
| November 4, 2010 | 57106 | Not yet classified | Terminated | Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura XPER FD 20 and Allura CV20. Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic an | Adjustment of the micro-switches in the footswitch used on the Philips cardiovascular X-ray systems was not implemented. If it is programmed for exposure, it is possible that after pressing the pedal on the footswitch it does not release itself. The patient may be exposed to X-ray longer than intended. | accessdata.fda.gov |
| October 7, 2010 | 57777 | Not yet classified | Terminated | Philips Allura Xper Systems with Velara Generator, x-ray system. FCO72200184. | A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown. | accessdata.fda.gov |
| September 22, 2010 | 56816 | Not yet classified | Terminated | HeartStart FR2+ AED with ECG Display, Model M3860, Philips brand, configurable manual charge in advance mode. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips | A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture. | accessdata.fda.gov |
| September 9, 2010 | 56707 | Not yet classified | Terminated | The BABIX holder is an accessory used with the BuckyDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during the examination. | Potential of broken strands in the main steel cable supporting the accessory holder used with BuckyDiagnost and DigitalDiagnost X-ray systems. | accessdata.fda.gov |
| May 28, 2010 | 55682 | Not yet classified | Terminated | HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand; configurable ECG on screen; configurable manual charge in advance mode. | Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable. | accessdata.fda.gov |
| April 30, 2010 | 55579 | Not yet classified | Terminated | Automated External Defibrillator (AED) of brand name "Philips HeartStart FRx" (Model number 861304). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing norma | Seventeen AEDs failed production line testing (Final Acceptance Test). | accessdata.fda.gov |
| February 5, 2010 | 57561 | Not yet classified | Terminated | The Panorama HFO system has the Traceable Item Identification (12NC): 9896 030 17741-SW R 2.5.1 (shipped as R 2.5.1, upgraded to R 2.5.3 via FCO). 9896 030 19641-SW R 2.5.3 9896 030 19861-SW R 2.6.1 9896 030 19862-SW R 2 | In the ExamCard MobiFlex the Patient Position is "Prone" which must be "Supine". The result is mislabeling of left and right side of the patient. If this is not detected by the operator there is a risk of wrong treatment or the need of additional X-RAY during treatment. | accessdata.fda.gov |
| February 4, 2010 | 56093 | Not yet classified | Terminated | MONOPLANE X-ray Imaging Systems include the Allura XPER FD10 F/C, Allura XPER FD20, Integris H5000/Allura 9 F/C, Integris CV, and Allura 12-15 Monoplane. The Monoplane system has one C-arm and it could be mounted on a ce | A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem could only resolved by a warm or cold system restart. In exceptional cases the power converters of the KVmA unit in the generator are damaged and the system can not be restarted. | accessdata.fda.gov |
| January 21, 2010 | 54641 | Not yet classified | Terminated | DigitalDiagnost. General radiographic examinations and applications wherever a solid state X-ray imaging device can be used. | Device failed to display appropriate labels indicating Radiation Symbol along with the required wording. | accessdata.fda.gov |
| November 2, 2009 | 53816 | Not yet classified | Terminated | Philips Heartstart FRx automated external defibrillator (AED), Model 861304 | Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated. | accessdata.fda.gov |
| October 1, 2009 | 53383 | Not yet classified | Terminated | Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. Model M3861A is under the Philips label and M3841A is under the Laerdal label. | A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy. | accessdata.fda.gov |
| July 6, 2009 | 53034 | Not yet classified | Terminated | EasyDiagnost | The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch | accessdata.fda.gov |
| May 26, 2009 | 57069 | Not yet classified | Terminated | MultiDiagnost Eleva with FD. The Philips MultiDiagnost Eleva intended use is for the following applications: As a diagnostic-imaging device multi-functional/ universal system, general R/F, Fluoroscopy, Radiography and An | The Printed Circuit Board (PCB) in the Main-cabinet. Further investigation revealed that a manufacturing error in the PCB is responsible for the reliability issue. As a result, the complete system may shut down and not re-start. | accessdata.fda.gov |
| May 12, 2009 | 57351 | Not yet classified | Terminated | Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit. Consists of diagnostic devices that produce cross sectional images, spectroscopy images and/or spectra in any orientation of the intern | The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system. | accessdata.fda.gov |
| May 1, 2009 | 52040 | Not yet classified | Terminated | The product's marketing brochure states: "1.5T coils and accessories...Philips Achieva and Intera 1.5T MR systems". The Identification of the Synergy Flex-M/ Shoulder Coil 1.5T can be found on the driver box. The 12nc of | Combined use of the Synergy Flex-M / Shoulder Coil 1.5T increases the chance of RF interaction and heating up of the coil. This may result in possible burns of the patient. | accessdata.fda.gov |
| March 6, 2009 | 57068 | Not yet classified | Terminated | Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips EasyDiagnost Eleva intended use is for the following applications: As a diagnostic-imaging device multi-functional/universal system, general R/ | Images from two different patients may be combined in one patient folder in the Digital Image (DI) or may be combined as one (printed) image. It is possible that an image of a previous patient registered in the DI will be overwritten with an image of a later patient. | accessdata.fda.gov |
| January 30, 2009 | 52108 | Not yet classified | Terminated | Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM Workstation is intended for the manipulation and display of medical images, including mammograms. It can show images from different modali | Review by firm of Philips EasyVision MM workstations found that to assure compliance with 21 CFR 900.12(c)(5) corrected software was needed so that all sites are in compliance. | accessdata.fda.gov |
| January 21, 2009 | 52100 | Not yet classified | Terminated | Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany. | Patient and image data can be exchanged when a patient is selected in the patient list and the examination tab is pressed with background query running at the same time. There is a risk that the data may then be linked to the incorrect patient, which may adversely affect diagnosis and treatment. | accessdata.fda.gov |
| December 30, 2008 | 50748 | Not yet classified | Terminated | Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher Used for general R/F, fluoroscopy, radiography, and angiography examinations. | System fails to meet requirements when it is used at kV levels greater than 115 kV at certain frame rates and in certain acquisition modes, as grid switch leakage may occur. | accessdata.fda.gov |
| December 23, 2008 | 57558 | Not yet classified | Terminated | PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Philips Electronics... www.medical.philips.com... Philips Medical Systems Nederland B.V". Provides one or more capabilities | There is a risk of selecting the wrong patient, when patient is selected in the patient list and the examination tab pressed with background query are running at the same time. | accessdata.fda.gov |
| December 10, 2008 | 50742 | Not yet classified | Terminated | Allura XPER 10/10 | Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch. | accessdata.fda.gov |
| November 21, 2008 | 50215 | Not yet classified | Terminated | The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini- jack cable (Agis | Potential for Internal Sound Amplifier to malfunction which could delay treatment. | accessdata.fda.gov |
| October 23, 2008 | 50114 | Not yet classified | Terminated | Philips Allura XPER 10/10 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 * (number located on the generator cabinet). Intended use for Angiographic X-ray system with an | A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display. | accessdata.fda.gov |
| September 30, 2008 | 49594 | Not yet classified | Terminated | Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x. | The cables of the coil may become too hot and cause burns when placed too close to the patient. While using the 1.5T Sense XL Torso coil, unwanted radiofrequencies (RF) interaction with the patient can occur. Especially in combination with high SAR levels and when the RF cables of the coil are too close to the patient, this RF interaction has resulted in RF | accessdata.fda.gov |
| September 19, 2008 | 49489 | Not yet classified | Terminated | Edge Nuclear Magnetic Resonance Imaging System. "1.5T Edge High-Field Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.". | Water may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite. | accessdata.fda.gov |
| September 10, 2008 | 50066 | Not yet classified | Terminated | Philips BV Pulsera Mobile X-Ray system with the extended rotation option. | The C-arm rotation brake does not always function properly, and may not hold the C-arm position if the C-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff or patients. Unwanted C-arm movement may cause the C-arm to collide with a patient. The brakes function properly if the C-arm is rotated to its maximum positio | accessdata.fda.gov |
| September 5, 2008 | 49605 | Not yet classified | Terminated | Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device's brochure is labeled | Reliability of the Stand-Trolley cable may result in loss of images on the monitor during an examination. This intermittent problem can lead to System lock-up, where no radiation is possible and images are not visible on the monitor | accessdata.fda.gov |
| August 21, 2008 | 49488 | Not yet classified | Terminated | Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), p | Due to a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible. | accessdata.fda.gov |
| August 15, 2008 | 49138 | Not yet classified | Terminated | Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography. It is designed for radiographic examina | When a patient is selected in the patient list and examination tab pressed with background query running at the same time, the wrong patient may be selected. | accessdata.fda.gov |
| August 7, 2008 | 49384 | Not yet classified | Terminated | Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304. | The affected device may not deliver appropriate defibrillation therapy. | accessdata.fda.gov |
| July 9, 2008 | 48998 | Not yet classified | Terminated | The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system. | Potential for bright artifacts to appear on the patient image from a previous exposure. | accessdata.fda.gov |
| June 26, 2008 | 48992 | Not yet classified | Terminated | Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems. Usage: Ceiling suspension unit with an actuator to hold monitors and X-ray shields. | Monitor ceiling carriage may separate from the monitor ceiling suspension. | accessdata.fda.gov |
| May 23, 2008 | 48602 | Not yet classified | Terminated | General X-Ray System types with Digital Spot Imaging (DSI) software | X-ray images may be stored in the wrong patient file or corrupted, images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted). | accessdata.fda.gov |
| April 30, 2008 | 47833 | Not yet classified | Terminated | Philips defibrillator, model M5066A. Sold in the US by Philips as an OTC under the brand name Philips "HeartStart On Site Defibrillator" and outside the U.S. by Philips with the brand name Philips "HeartStart Defibrillat | Buttons Sticking - The On/Off and Shock buttons on the front panel of the device may stick in place when pressed and fail to respond to the button press, causing a delay in the delivery of a defibrillation shock when the system advises a shock. | accessdata.fda.gov |
| April 10, 2008 | 50138 | Not yet classified | Terminated | NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam | An issue associated with the "Timed Scan" application was found. The system does not wait for the programmed time interval and starts the x-ray after selection of the scan button when certain criteria is met. | accessdata.fda.gov |
| April 8, 2008 | 47539 | Not yet classified | Terminated | Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and lower). The device is intended for routine exams, including specialist areas like trauma or pediatric work, excluding mammography. | Bright artifacts may appear on a patient image from a previous exposure, which might lead to a misdiagnosis. | accessdata.fda.gov |
| March 22, 2008 | 47489 | Not yet classified | Terminated | Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. | Unexpected movement of the X-ray table may occur. These movements may lead to patient injury, e.g., an uncontrolled tilt may cause the patient to slip off. | accessdata.fda.gov |
| March 14, 2008 | 47487 | Not yet classified | Terminated | AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be purchased with a tilt option. | Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation. | accessdata.fda.gov |
| March 10, 2008 | 47775 | Not yet classified | Terminated | EasyVision RAD - Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V2L4, SW R4 2V2L5, SW R4 2V2L6, and SW R4 2V2L7. The EasyVision RAD consists of a computer with digital interfaces, one o | Inaccurate measurements when exporting radiography images to Picture Archiving and Communication System (PACS ). | accessdata.fda.gov |
| February 7, 2008 | 46216 | Not yet classified | Terminated | Philips Gallileo Automatic Collimator, Part Numbers: 9896 010 00612, 9896 010 00614, 9896 010 00615. The device is a diagnostic x-ray beam-limiting device intended to restrict the dimensions of a diagnostic x-ray field b | The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath. | accessdata.fda.gov |
| January 4, 2008 | 46217 | Not yet classified | Terminated | Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot. Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography ca | Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path. | accessdata.fda.gov |
| December 13, 2007 | 47477 | Not yet classified | Terminated | DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identified with Part Number 4512 201 04752 Software Version 1.5.1 and Part Number 4512 201 04753 Software Ve | When using DICOM print functionality, the printed images may contain data for the wrong patient. | accessdata.fda.gov |
| November 29, 2007 | 45959 | Not yet classified | Terminated | MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems, Bothell, WA, 98021 | Delay in Imaging: MultiDiagnost Eleva with Flat Detector x-ray system cannot perform fluoroscopy procedures while certain image file housekeeping operations are performed. Fluoroscopy cannot be performed and new exposures are not able to be acquired until the housekeeping operations are complete which may take several minutes. The loss of system availability | accessdata.fda.gov |
| September 24, 2007 | 44959 | Not yet classified | Terminated | Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021 | Inaccurate anatomical measurements when using the optional SmartMask feature | accessdata.fda.gov |
| August 23, 2007 | 39392 | Not yet classified | Terminated | Philips Medical System - BV Pulsera Mobile C-arms with Remote Control Option, (Release 2) | System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control. | accessdata.fda.gov |
| July 23, 2007 | 44910 | Not yet classified | Terminated | Philips Bucky DIagnost X-Ray System | Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures. | accessdata.fda.gov |
| April 30, 2007 | 37950 | Not yet classified | Terminated | Gyroscan MRI | Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site. | accessdata.fda.gov |
| March 23, 2007 | 37844 | Not yet classified | Terminated | Practix 33 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations. | X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce. | accessdata.fda.gov |
| March 15, 2007 | 37767 | Not yet classified | Terminated | Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and 9804 602 83501. Product is a Collimator/ Beam Limiting Device and are replacement components for the Bucky Diagnost TH X-ray system. | The Collimator field-defining light beam does not meet the light field contrast ratio requirement of 4:1. System is non-compliant with performance standard (1020.31 (d)(2)(iii) 21 CFR | accessdata.fda.gov |
| February 28, 2007 | 37477 | Not yet classified | Terminated | Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED) Catalog Numbers: M3860A/M3861A/M3840A/M3841A | Failure of tactile switches on one of two printed circuit board assemblies (PCBA) used in the FR2+ device. Potential delay or prevention of shock treatment due to PCBA board contamination, causing intermittent switch operation. | accessdata.fda.gov |
| December 19, 2006 | 36662 | Not yet classified | Terminated | HeartStart FR2+ Defibrillator | Potential for shock treatment to be delayed or prevented due to board contamination that causes intermittent switch operation | accessdata.fda.gov |
| December 14, 2006 | 37012 | Not yet classified | Terminated | Philips Integris Allura x-ray systems angiographic - Allura 9 F/C (floor and ceiling models). A mono-plane analog Allura with a 9' Image Intensifier | Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested. | accessdata.fda.gov |
| October 12, 2006 | 36573 | Not yet classified | Terminated | Allura X-per FD 10/10 x-ray, and fluoroscopy | Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue. | accessdata.fda.gov |
| August 24, 2006 | 36196 | Not yet classified | Terminated | Allura Xper FD 10/10 x-ray, angiographic system | Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned. | accessdata.fda.gov |
| July 1, 2006 | 35838 | Not yet classified | Terminated | Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Option | Potential for measurements, lines, texts, etc to be stored incorrectly. | accessdata.fda.gov |
| April 6, 2006 | 35177 | Not yet classified | Terminated | MD3 X-ray system | Potential for unexpected table movement. | accessdata.fda.gov |
| February 6, 2006 | 34602 | Not yet classified | Terminated | Allura Xper FD10/10 x-ray system | Potential lock-up of system requiring reboot of system. | accessdata.fda.gov |
| December 9, 2005 | 34207 | Not yet classified | Terminated | Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging. | The Gyroscan NT MRI system has a computer software problem which results in images from one patient being placed into another patient's image record. | accessdata.fda.gov |
| October 12, 2005 | 33873 | Not yet classified | Terminated | AD5 table for use with Integris and Integris Allura x-ray systems | Potential for high voltage exposure involving the injector interface connector of patient support tables. | accessdata.fda.gov |
| July 27, 2005 | 33014 | Not yet classified | Terminated | Interis Allura BiPlane X-Ray System | 1) During positioning of the Lateral Stand the rotation and/or skew movement may travel unexpectedly in opposite direction; 2) movement may be faster than normal speed; 3) the stand may not stop immediately upon release of the joystick. | accessdata.fda.gov |
| April 29, 2005 | 31997 | Not yet classified | Terminated | View Forum 2003 software, SW 3.4L1 | Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10. | accessdata.fda.gov |
| February 16, 2005 | 31233 | Not yet classified | Terminated | Easy Access Image Management System with CL.Net. | Failure to update correctly when re-transmitting an image from the modality. | accessdata.fda.gov |
| February 10, 2005 | 31277 | Not yet classified | Terminated | Tomoscan | Potential for shift of reference lines. | accessdata.fda.gov |
| December 21, 2004 | 30780 | Not yet classified | Terminated | Xcelera R1.2 Cardiology image and information management solution software. | Loss of image data from image repository and archive requiring patients to undergo repeat imaging. | accessdata.fda.gov |
| December 1, 2004 | 30569 | Not yet classified | Terminated | Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811 | X-Ray system may fall downward and could possibly hit the patient. | accessdata.fda.gov |
| August 20, 2004 | 29966 | Not yet classified | Terminated | NT Intera Magnetic Resonance Image System | Potential for patient burn | accessdata.fda.gov |
| July 20, 2004 | 29855 | Not yet classified | Terminated | BV25 Mobile X-Ray System | Potential for c-arm to move due to loose screws | accessdata.fda.gov |
| June 8, 2004 | 29470 | Not yet classified | Terminated | EasyDiagnost Eleva Part Number 989605071921 | When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination. | accessdata.fda.gov |
| May 13, 2004 | 29229 | Not yet classified | Terminated | Trolley for Intera/NT MRI System | Patient and MRI tabletop may fall if the tabletop is not positioned correctly on the MRI trolley. | accessdata.fda.gov |
| April 15, 2004 | 28937 | Not yet classified | Terminated | Xcelera System, image processing, radiological. | Potential for the image data to be erased from the long term archive. | accessdata.fda.gov |
| November 20, 2003 | 27839 | Not yet classified | Terminated | Digital Diagnost VE | The support chain attachment on the detector carriage may fail and cause the counter weights or detector to fall. | accessdata.fda.gov |
| November 18, 2003 | 27827 | Not yet classified | Terminated | Bucky Diagnost FS Part number 9890-010-83651 | Support chain attachment on the Bucky carriage may fail and cause the counter weights or X-ray tube to fall. | accessdata.fda.gov |
| October 10, 2003 | 27485 | Not yet classified | Terminated | Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C | The cable carrier and cables may fall after repeat collisions with OR lamps, radiation shields or other supported accessories. | accessdata.fda.gov |
| October 10, 2003 | 27477 | Not yet classified | Terminated | Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems. | The thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall. | accessdata.fda.gov |
| August 10, 2003 | 27013 | Not yet classified | Terminated | Diagnost 96 | Potential for table to move by itself | accessdata.fda.gov |
| July 17, 2003 | 26837 | Not yet classified | Terminated | OmniDiagnost System | Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID). | accessdata.fda.gov |
| June 27, 2003 | 26514 | Not yet classified | Terminated | Easy Access Software releases 1.1, 5.2, 6.2 & 7.2 | If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems. | accessdata.fda.gov |
| January 10, 2003 | 25406 | Not yet classified | Terminated | MultiDiagnost 4 - x-ray system, multi functional/universal system for general use. | INTERNAL SHORT CIRCUIT - MAY ALLOW FOR STAND AND TABLE TO MOVE SPONTANEOUSLY IN UPWARD OR DOWNWARD MOVEMENT | accessdata.fda.gov |
| November 21, 2002 | 26580 | Not yet classified | Terminated | Gyroscan ACS-NT with software versions R6x, R7x, R8x | Patient burns from cables near or in contact with the patient during use | accessdata.fda.gov |
| September 27, 2002 | 25248 | Not yet classified | Terminated | Philips BV300 Mobile X-Ray System | The C-bow support can bend and break allowing C-arm to fall from support | accessdata.fda.gov |
| May 2, 2002 | 26579 | Not yet classified | Terminated | Gyroscan ACS-NT system | Patient burns related to high SAR levels and the combined use of Synergy Body Coil and synergy Flex-M coil | accessdata.fda.gov |
| February 20, 2002 | 26581 | Not yet classified | Terminated | Diagnost 94 | Spontaneous movement of table without input from an operator | accessdata.fda.gov |
| February 13, 2002 | 26583 | Not yet classified | Terminated | EasyWeb | Potential for incorrect body part information | accessdata.fda.gov |
| February 13, 2002 | 26547 | Not yet classified | Terminated | Easy Access PACS System with software Release 5, 6.2, or 7.2 | Potential display of an incorrect body part description on patient images. | accessdata.fda.gov |
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Updated May 21, 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.