Philips North America
Cambridge, MA
This page shows every FDA and USDA recall linked to Philips North America. 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.
107
Total Recalls
2020
First Recall
2026
Most Recent
Ingenia Ambition S.
Product Code (REF): 782108.
MR systems with SW version R11.1 and R12.1.
Jan 29, 2026
· Device
Open, Classified
Ingenia Elition X.
Product Code (REF): (1) 781358, (2) 782107, (3) 782136.
MR systems with SW version R11.1...
Jan 29, 2026
· Device
Open, Classified
Evolution Upgrade 3.0T.
Product Code (REF): 782143.
MR systems with SW version R11.1 and R12.1.
Jan 29, 2026
· Device
Open, Classified
Ingenia Ambition X.
Product Code (REF): (1) 781356, (2) 782109, (3)782138.
MR systems with SW version R11.1...
Jan 29, 2026
· Device
Open, Classified
SmartPath to dStream for 3.0T.
Product Code (REF): 782145.
MR systems with SW version R11.1 and R12.1.
Jan 29, 2026
· Device
Open, Classified
Upgrade to MR 7700.
Product Code (REF): 782130.
MR systems with SW version R11.1 and R12.1.
Jan 29, 2026
· Device
Open, Classified
Evolution Upgrade 1.5T.
Product Codes (REF): (1) 782148, (2) 782116.
MR systems with SW version R11.1 and R1...
Jan 29, 2026
· Device
Open, Classified
Ingenia 1.5T.
Product Code (REF): (1) 781341, (2) 781396.
MR systems with SW version R11.1 and R12.1.
Jan 29, 2026
· Device
Open, Classified
MR 7700.
Product Code (REF): (1) 782120, (2) 782153.
MR systems with SW version R11.1 and R12.1.
Jan 29, 2026
· Device
Open, Classified
Ingenia 3.0T.
Product Code (REF): (1) 781342, (2) 781377.
MR systems with SW version R11.1 and R12.1.
Jan 29, 2026
· Device
Open, Classified
SmartPath to dStream for XR and 3.0T.
Product Code (REF): 781270.
MR systems with SW version R11.1 and R12.1...
Jan 29, 2026
· Device
Open, Classified
Ingenia Elition S.
Product Code (REF): (1) 781357, (2) 782106, (3)782137.
MR systems with SW version R11.1 a...
Jan 29, 2026
· Device
Open, Classified
Ingenia 3.0T CX.
Product Code (REF): 781271.
MR systems with SW version R11.1 and R12.1.
Jan 29, 2026
· Device
Open, Classified
Patient Information Center iX;
Software Version Number: 4.5.0
Jan 22, 2026
· Device
Open, Classified
Azurion R3.0.
Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Dec 9, 2025
· Device
Open, Classified
Cardiac Workstation 5000;
Model Number: 860439;
Oct 16, 2025
· Device
Open, Classified
Cardiac Workstation 7000;
Model Number: 860441;
Oct 16, 2025
· Device
Open, Classified
Ingenia Elition X
Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY)...
Jul 30, 2025
· Device
Open, Classified
Intera 3.0T Quasar Dual
Model Number (REF): 781150;
Jul 30, 2025
· Device
Open, Classified
Evolution Upgrade 1.5T
Model Numbers (REF): (1) 782116, (2) 782148;
Jul 30, 2025
· Device
Open, Classified
MR 7700
Model Numbers (REF): (1) 782120, (2) 782153;
Jul 30, 2025
· Device
Open, Classified
Ingenia Elition S
Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Jul 30, 2025
· Device
Open, Classified
Ingenia 1.5T S
Model Number (REF): 781347;
Jul 30, 2025
· Device
Open, Classified
SmartPath to dStream for XR and 3.0T
Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
Jul 30, 2025
· Device
Open, Classified
MR 5300
Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
Jul 30, 2025
· Device
Open, Classified
Ingenia Ambition S
Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
Jul 30, 2025
· Device
Open, Classified
Ingenia 3.0T
Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
Jul 30, 2025
· Device
Open, Classified
Evolution Upgrade 3.0T
Model Numbers (REF): (1) 782117, (2) 782143;
Jul 30, 2025
· Device
Open, Classified
Ingenia 1.5T
Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Jul 30, 2025
· Device
Open, Classified
Ingenia 3.0T CX
Model Numbers (REF): (1) 781271, (2) 782105;
Jul 30, 2025
· Device
Open, Classified
SmartPath to Ingenia Elition X
Model Numbers (REF): (1) 782118, (2) 782144;
Jul 30, 2025
· Device
Open, Classified
SmartPath to dStream for 3.0T
Model Number (REF): 782145;
Jul 30, 2025
· Device
Open, Classified
Ingenia Ambition X
Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
Jul 30, 2025
· Device
Open, Classified
Achieva 3.0T;
Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
Jul 30, 2025
· Device
Open, Classified
Achieva XR;
Model Numbers (REF): (1) 781153, (2) 781253;
Jul 30, 2025
· Device
Open, Classified
Upgrade to MR 7700
Model Number (REF): 782130;
Jul 30, 2025
· Device
Open, Classified
Intera 1.5T Achieva IT Nova
Product Number: 781175
Jun 9, 2025
· Device
Open, Classified
Intera 1.5T Master/Nova
Product Number: 781106;
Jun 9, 2025
· Device
Open, Classified
Intera 1.5T Achieva Nova-Dual
Product Number: 781173;
Jun 9, 2025
· Device
Open, Classified
Intera Achieva 1.5T Pulsar;
Product Number: 781171;
Jun 9, 2025
· Device
Open, Classified
Intera 1.5T Explorer/Nova Dual
Product Number: 781108;
Jun 9, 2025
· Device
Open, Classified
Achieva XR
Product Numbers: (1) 781153, (2) 781253;
Jun 9, 2025
· Device
Open, Classified
SmartPath to dStream for 1.5T;
Product Number: 782146;
Jun 9, 2025
· Device
Open, Classified
Intera 1.5T Achieva Nova
Product Number: 781172;
Jun 9, 2025
· Device
Open, Classified
Intera 1.5T Omni/Stellar;
Product Number: 781104;
Jun 9, 2025
· Device
Open, Classified
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866...
Oct 8, 2024
· Device
Open, Classified
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Oct 1, 2024
· Device
Open, Classified
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Sep 30, 2024
· Device
Open, Classified
Veradius Unity Mobile Surgery C-arm
Sep 30, 2024
· Device
Open, Classified
Azurion IGTS Fixed Systems
Sep 30, 2024
· Device
Open, Classified