Philips Medical Systems North America, Inc.
Country not established
- Devices
- 95
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What Philips Medical Systems North America, Inc. makes
The company manufactures software and hardware for medical imaging, including stereotaxis simulation tools for breast biopsy procedures, cephalometric and panoramic dental X-ray systems, Doppler ultrasound options for vascular imaging, and digital radiography systems like the Philips Bucky Diagnostic family. It also produces MRI coils, such as the quadrature body coil for 3.0T systems, and MRI-specific software and workstations, including the Philips EasyVision platform and GyroScan MRI series. Additional offerings include CT biopsy guidance tools and specialized MRI coils like the Synergy Head/Neck Coil.
The portfolio includes devices classified under FDA categories Class I, Class II, and Class III, with regulatory submissions supported via the 510(k) pathway. These products are listed in the FDA’s 510(k) registry, reflecting their authorised status under US medical device regulations. The company operates from its US headquarters in North America.
Catalogue
Search and filter all 95 devicesShowing 1-50 of 95
FDA recalls
FDA recall records list 5 recalls initiated by Philips Medical Systems North America, Inc., the earliest on 2013-10-17 and the most recent on 2014-02-28. By recorded status: 5 terminated. The reasons filed fall into these groups: software or firmware, sterility or contamination, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 28 Feb 2014 Z-1263-2014 Class II Terminated 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 velocity results table may be overstated by
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- 28 Feb 2014 Z-1264-2014 Class II Terminated 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 velocity results table may be overstated b
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- 6 Feb 2014 Z-1225-2014 Class II Terminated 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 be ready to deliver a shock in the event of an emergency.
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- 6 Feb 2014 Z-1232-2014 Class II Terminated 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 unable to deliver therapy in an emergency.
- 28 Feb 2014 Z-1263-2014 Class II Terminated 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 velocity results table may be overstated by
2013
- 17 Oct 2013 Z-0368-2014 Class II Terminated 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).
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- 17 Oct 2013 Z-0368-2014 Class II Terminated 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).
Frequently asked questions
How many devices does Philips Medical Systems North America, Inc. have in the registry?
The registry currently lists 95 devices for Philips Medical Systems North America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Philips Medical Systems North America, Inc.'s devices?
Among its 50 most recently registered devices, Philips Medical Systems North America, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Philips Medical Systems North America, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Philips Medical Systems North America, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Philips Medical Systems North America, Inc.?
FDA recall records list 5 recalls initiated by Philips Medical Systems North America, Inc., the most recent initiated on 28 Feb 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Philips Medical Systems North America, Inc. in the registry?
The most recently registered devices listed for Philips Medical Systems North America, Inc. include TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE, INTEGRIS 3D-RA, RELEASE 4.2, EP NAVIGATOR R3 and ORTHORALIX SD/ORTHORALIX SD CEPH.