FDA Device Recalls

Recalls / Firms / Philips North America

Philips North America

107 FDA device recalls on record.

DateClassProductReason
2025-12-22Patient Information Center iX; Software Version Number: 4.5.0
2025-12-03MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
2025-12-03Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
2025-12-03Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
2025-12-03Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW versi
2025-12-03Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW vers
2025-12-03SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R1
2025-12-03SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1
2025-12-03Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R1
2025-12-03Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW vers
2025-12-03Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12
2025-12-03Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12
2025-12-03Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
2025-12-03Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
2025-10-27Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRA
2025-09-12Cardiac Workstation 7000; Model Number: 860441;
2025-09-12Cardiac Workstation 5000; Model Number: 860439;
2025-06-30Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
2025-06-30Upgrade to MR 7700 Model Number (REF): 782130;
2025-06-30Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
2025-06-30Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
2025-06-30Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139
2025-06-30Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 7
2025-06-30Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
2025-06-30MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;
2025-06-30Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
2025-06-30MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
2025-06-30Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
2025-06-30Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
2025-06-30Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (
2025-06-30SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
2025-06-30Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
2025-06-30SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
2025-06-30SmartPath to dStream for 3.0T Model Number (REF): 782145;
2025-06-30Intera 3.0T Quasar Dual Model Number (REF): 781150;
2025-06-30Ingenia 1.5T S Model Number (REF): 781347;
2025-05-29Intera 1.5T Explorer/Nova Dual Product Number: 781108;
2025-05-29Achieva XR Product Numbers: (1) 781153, (2) 781253;
2025-05-29Intera 1.5T Omni/Stellar; Product Number: 781104;
2025-05-29Intera Achieva 1.5T Pulsar; Product Number: 781171;
2025-05-29SmartPath to dStream for 1.5T; Product Number: 782146;
2025-05-29Intera 1.5T Achieva Nova Product Number: 781172;
2025-05-29Intera 1.5T Master/Nova Product Number: 781106;
2025-05-29Intera 1.5T Achieva Nova-Dual Product Number: 781173;
2025-05-29Intera 1.5T Achieva IT Nova Product Number: 781175
2024-08-30IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Nu
2024-02-28Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PI
2024-02-28CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Ver
2024-01-03Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
2024-01-03Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
2024-01-03Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
2024-01-03Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
2024-01-03Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
2024-01-03Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
2024-01-03SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
2024-01-03Achieva XR. Model (REF) Numbers 781153, 781253.
2024-01-03Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
2024-01-03Achieva 1.5T Initial system. Model (REF) Numbers 781178.
2024-01-03Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
2024-01-03SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
2023-12-29Achieva 3.0T, Model No. 781177
2023-12-29Achieva 1.5T Conversion, Model No. 781283
2023-12-29Ingenia Ambition X, Model No. 782109
2023-12-29Intera 1.5T, Model No. 781195
2023-12-29Achieva 1.5T, Model No. 781178, 781196, 781296
2023-12-29SmartPath to dStream for 1.5T, Model No. 781260, 782112
2023-12-15ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:70615
2023-12-15BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 4535604
2023-12-15ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)70610
2023-12-15BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 4
2023-12-15BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824
2023-12-07Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part numbe
2023-11-30BrightView, Gamma Camera System, Product Code 882480.
2023-11-30BrightView X, Gamma Camera, Product Code 882478
2023-11-30BrightView XCT, Gamma Camera, Product Code 882482
2023-11-28(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model
2023-11-28(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
2023-10-09Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
2023-10-09Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
2023-10-04Zenition 50 & 70 Mobile Surgery C-arm
2023-10-04Veradius Unity Mobile Surgery C-arm
2023-10-04BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
2023-10-04Integris-Allura IGTS Fixed Systems
2023-10-04Allura Xper IGTS Fixed Systems
2023-10-04Azurion IGTS Fixed Systems
2023-06-12MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
2023-06-12Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
2023-06-12Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartP
2023-06-12MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
2023-06-12Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
2023-06-12Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartP
2023-04-25Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
2023-04-25Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
2023-04-25Incisive CT-Computed Tomography X-Ray System Model: 728143
2023-04-25Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
2023-04-19Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Produc
2023-03-20Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
2023-03-20Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
2023-03-03CombiDiagnost R90 R.1.0
2023-03-03ProxiDiagnost N90 R.1.0
2023-03-03CombiDiagnost R90 R1.1
2023-01-18IntelliVue G7m Anesthesia Gas Module, Product Number 866173
2022-01-06Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient trans
2022-01-06Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient
2022-01-06Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient
2021-07-15(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
2020-12-24PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to