Philips North America
74 recalls on record · Latest: Feb 4, 2026
FDA Devices Moderate Feb 4, 2026
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
FDA Devices Moderate Feb 4, 2026
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
FDA Devices Moderate Feb 4, 2026
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
FDA Devices Moderate Feb 4, 2026
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
FDA Devices Moderate Feb 4, 2026
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
FDA Devices Moderate Feb 4, 2026
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
FDA Devices Moderate Feb 4, 2026
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
FDA Devices Moderate Feb 4, 2026
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
FDA Devices Moderate Feb 4, 2026
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
FDA Devices Moderate Feb 4, 2026
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
FDA Devices Moderate Feb 4, 2026
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
FDA Devices Moderate Feb 4, 2026
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
FDA Devices Moderate Dec 17, 2025
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
FDA Devices Moderate Oct 22, 2025
Cardiac Workstation 5000; Model Number: 860439;
FDA Devices Moderate Aug 6, 2025
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
FDA Devices Moderate Aug 6, 2025
SmartPath to dStream for 3.0T Model Number (REF): 782145;
FDA Devices Moderate Aug 6, 2025
Ingenia 1.5T S Model Number (REF): 781347;
FDA Devices Moderate Aug 6, 2025
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
FDA Devices Moderate Aug 6, 2025
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
FDA Devices Moderate Aug 6, 2025
Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
FDA Devices Moderate Aug 6, 2025
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
FDA Devices Moderate Aug 6, 2025
Upgrade to MR 7700 Model Number (REF): 782130;
FDA Devices Moderate Aug 6, 2025
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
FDA Devices Moderate Aug 6, 2025
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
FDA Devices Moderate Aug 6, 2025
Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
FDA Devices Moderate Aug 6, 2025
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
FDA Devices Moderate Aug 6, 2025
Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
FDA Devices Moderate Aug 6, 2025
Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
FDA Devices Moderate Aug 6, 2025
Intera 3.0T Quasar Dual Model Number (REF): 781150;
FDA Devices Moderate Jun 18, 2025
Intera 1.5T Achieva Nova-Dual Product Number: 781173;
FDA Devices Moderate Jun 18, 2025
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
FDA Devices Moderate Jun 18, 2025
SmartPath to dStream for 1.5T¿; Product Number: 782146;
FDA Devices Moderate Jun 18, 2025
Intera 1.5T Achieva IT Nova Product Number: 781175
FDA Devices Moderate Oct 16, 2024
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
FDA Devices Moderate Apr 3, 2024
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
FDA Devices Moderate Apr 3, 2024
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
FDA Devices Moderate Feb 21, 2024
ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
FDA Devices Moderate Feb 21, 2024
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
FDA Devices Critical Feb 14, 2024
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4…
FDA Devices Moderate Feb 14, 2024
Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
FDA Devices Critical Feb 14, 2024
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
FDA Devices Moderate Feb 14, 2024
Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
FDA Devices Critical Feb 14, 2024
BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;
FDA Devices Moderate Feb 7, 2024
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
FDA Devices Moderate Feb 7, 2024
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
FDA Devices Moderate Feb 7, 2024
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
FDA Devices Moderate Feb 7, 2024
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
FDA Devices Moderate Feb 7, 2024
Achieva XR. Model (REF) Numbers 781153, 781253.
FDA Devices Moderate Feb 7, 2024
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
FDA Devices Moderate Feb 7, 2024