Philips North America Llc
Cambridge, MA
This page shows every FDA and USDA recall linked to Philips North America Llc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
301
Total Recalls
2020
First Recall
2026
Most Recent
The Allura Xper series is intended for use on human patients to perform:
"Vascular, cardiovascular and neurov...
Aug 13, 2021
· Device
Terminated
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurova...
Aug 13, 2021
· Device
Terminated
Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic devic...
Aug 11, 2021
· Device
Completed
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The sys...
Aug 11, 2021
· Device
Completed
Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. Th...
Aug 11, 2021
· Device
Completed
Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The...
Aug 11, 2021
· Device
Completed
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The s...
Aug 11, 2021
· Device
Completed
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. T...
Aug 11, 2021
· Device
Completed
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The sy...
Aug 11, 2021
· Device
Completed
SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a di...
Aug 11, 2021
· Device
Completed
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The...
Aug 11, 2021
· Device
Completed
Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. Th...
Aug 11, 2021
· Device
Completed
SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnosti...
Aug 11, 2021
· Device
Completed
Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. Th...
Aug 11, 2021
· Device
Completed
Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. The...
Jul 30, 2021
· Device
Terminated
Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. The syst...
Jul 30, 2021
· Device
Terminated
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. The syst...
Jul 30, 2021
· Device
Terminated
Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. The s...
Jul 30, 2021
· Device
Terminated
Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. The syst...
Jul 30, 2021
· Device
Terminated
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device....
Jul 30, 2021
· Device
Terminated
Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. The...
Jul 30, 2021
· Device
Terminated
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Jun 8, 2021
· Device
Terminated
728306 Brilliance iCT-Computed Tomography X-ray systems
728305 Brilliance iCT Upgrades
Jun 8, 2021
· Device
Terminated
728332 IQon Spectral CT-Computed Tomography X-ray system
Jun 8, 2021
· Device
Terminated
728333 Spectral CT 7500 -Computed Tomography X-ray system
Jun 8, 2021
· Device
Terminated
Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
Jun 8, 2021
· Device
Terminated
Ingenia Ambition S - Model Number: 781359
Diagnostic MR system.
Jun 4, 2021
· Device
Active
Ingenia Ambition X - Model Number: 781356,
Diagnostic MR system.
***Updated November 2023*** Added Model Numb...
Jun 4, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
728306 - Brilliance iCT
728311...
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16
System Number: 882470
Cont...
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT an...
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
728333 - Spectral CT:
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT an...
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice
System Number: 882410...
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT an...
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT
System Number: 88...
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64
System Number: 882471
Contin...
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT an...
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
882476 - Gemini TF Big Bore PET...
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
882446 - Vereos PET/CT
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT
System Number: 728209...
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
Ingenuity Core, Ingenuity Core 12...
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT an...
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
728332 - IQon Spectral CT
:...
May 1, 2021
· Device
Active
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
882442/882456 - Ingenuity TF PET/...
May 1, 2021
· Device
Active
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body....
Apr 13, 2021
· Device
Terminated
Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by pr...
Mar 29, 2021
· Device
Active
Incisive CT Computed Tomography X-ray System
Model: 728143
Feb 22, 2021
· Device
Terminated
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Prod...
Feb 2, 2021
· Device
Terminated
Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and r...
Nov 18, 2020
· Device
Terminated