FDA recall record · openFDA
Philips North America
121 FDA recalls on record (2023–2026) — 121 device. 121 still ongoing.
3
Class I (most serious)
112
Class II
6
Class III
121
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination 19
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a pot 19
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Ar 13
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If t 12
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act 9
Recalls
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 4 Class I 2023-12-15 BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 45356074 Class I 2023-12-15 BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 4535608292 Class I 2023-12-15 Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145. Class II 2026-04-14 Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Numbe Class II 2026-04-14 Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. Class II 2026-04-14 Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): Class II 2026-04-14 Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782 Class II 2026-04-14 Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296. Class II 2026-04-14 Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262. Class II 2026-04-14 Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 7821 Class II 2026-04-14 Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105 Class II 2026-04-14 Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178. Class II 2026-04-14 Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. Class II 2026-04-14 Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153. Class II 2026-04-14 Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278. Class II 2026-04-14 Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 7 Class II 2026-04-14 Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 7821 Class II 2026-04-14 Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130. Class II 2026-04-14 Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782 Class II 2026-04-14 Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Class II 2026-04-14 Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number Class II 2026-04-14 Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY); Class II 2025-06-30 SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1. Class II 2025-12-03 Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1. Class II 2025-12-03 Intera 1.5T Achieva Nova-Dual Product Number: 781173; Class II 2025-05-29 SmartPath to dStream for 3.0T Model Number (REF): 782145; Class II 2025-06-30 Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1. Class II 2025-12-03 Ingenia 1.5T S Model Number (REF): 781347; Class II 2025-06-30 Cardiac Workstation 5000; Model Number: 860439; Class II 2025-09-12 Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103; Class II 2025-06-30 Intera 1.5T Explorer/Nova Dual Product Number: 781108; Class II 2025-05-29 SmartPath to dStream for 1.5T¿; Product Number: 782146; Class II 2025-05-29 MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152; Class II 2025-06-30 Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139; Class II 2025-06-30 Intera 1.5T Achieva IT Nova Product Number: 781175 Class II 2025-05-29 Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1. Class II 2025-12-03 MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1. Class II 2025-12-03 Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1. Class II 2025-12-03 Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345; Class II 2025-06-30 Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12. Class II 2025-12-03 Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1. Class II 2025-12-03 Upgrade to MR 7700 Model Number (REF): 782130; Class II 2025-06-30 Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105; Class II 2025-06-30 Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY); Class II 2025-06-30 Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM Class II 2025-10-27 SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1. Class II 2025-12-03 Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12. Class II 2025-12-03 Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253; Class II 2025-06-30 SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144; Class II 2025-06-30 Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1 Class II 2025-12-03 Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143; Class II 2025-06-30 Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1. Class II 2025-12-03 Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148; Class II 2025-06-30 Intera 3.0T Quasar Dual Model Number (REF): 781150; Class II 2025-06-30 Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140; Class II 2025-06-30 Intera 1.5T Achieva Nova Product Number: 781172; Class II 2025-05-29 SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129; Class II 2025-06-30 Intera Achieva 1.5T Pulsar; Product Number: 781171; Class II 2025-05-29 Patient Information Center iX; Software Version Number: 4.5.0 Class II 2025-12-22 Intera 1.5T Master/Nova Product Number: 781106; Class II 2025-05-29 MR 7700 Model Numbers (REF): (1) 782120, (2) 782153; Class II 2025-06-30 Intera 1.5T Omni/Stellar; Product Number: 781104; Class II 2025-05-29 Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1. Class II 2025-12-03 Cardiac Workstation 7000; Model Number: 860441; Class II 2025-09-12 Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; Class II 2025-06-30 Achieva XR Product Numbers: (1) 781153, (2) 781253; Class II 2025-05-29 Intera 1.5T Achieva Nova. Model (REF) Numbers 781172. Class II 2024-01-03 SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129. Class II 2024-01-03 Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105. Class II 2024-01-03 Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296. Class II 2024-01-03 Achieva XR. Model (REF) Numbers 781153, 781253. Class II 2024-01-03 CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X Class II 2024-02-28 Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) runni Class II 2024-02-28 Achieva 1.5T Initial system. Model (REF) Numbers 781178. Class II 2024-01-03 Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345. Class II 2024-01-03 Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261. Class II 2024-01-03 Intera Achieva 1.5T Pulsar. Model (REF) Number 781171. Class II 2024-01-03 Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283. Class II 2024-01-03 Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173. Class II 2024-01-03 IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 Class II 2024-08-30 SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112. Class II 2024-01-03 Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 Class II 2023-10-09 Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Softw Class II 2023-04-19 ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150 Class II 2023-12-15 BrightView X, Gamma Camera, Product Code 882478 Class II 2023-11-30 Allura Xper IGTS Fixed Systems Class II 2023-10-04 ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110 Class II 2023-12-15 BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems. Class II 2023-10-04 Veradius Unity Mobile Surgery C-arm Class II 2023-10-04 ProxiDiagnost N90 R.1.0 Class II 2023-03-03 CombiDiagnost R90 R.1.0 Class II 2023-03-03 Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Eliti Class II 2023-06-12 Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146 Class II 2023-04-25 Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871 Class II 2023-12-07 (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC Class II 2023-11-28 BrightView, Gamma Camera System, Product Code 882480. Class II 2023-11-30 MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) Class II 2023-06-12 CombiDiagnost R90 R1.1 Class II 2023-03-03 Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Eliti Class II 2023-06-12 Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 Class II 2023-10-09 BrightView XCT, Gamma Camera, Product Code 882482 Class II 2023-11-30 Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813 Class II 2023-03-20 MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) Class II 2023-06-12 Zenition 50 & 70 Mobile Surgery C-arm Class II 2023-10-04 (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436 Class II 2023-11-28 IntelliVue G7m Anesthesia Gas Module, Product Number 866173 Class II 2023-01-18 Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 Class II 2023-06-12 Azurion IGTS Fixed Systems Class II 2023-10-04 Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814 Class II 2023-03-20 Incisive CT-Computed Tomography X-Ray System Model: 728143 Class II 2023-04-25 Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 Class II 2023-06-12 Integris-Allura IGTS Fixed Systems Class II 2023-10-04 Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148 Class II 2023-04-25 Incisive CT Plus-Computed Tomography X-Ray System Model: 728149 Class II 2023-04-25 Achieva 3.0T, Model No. 781177 Class III 2023-12-29 SmartPath to dStream for 1.5T, Model No. 781260, 782112 Class III 2023-12-29 Intera 1.5T, Model No. 781195 Class III 2023-12-29 Achieva 1.5T, Model No. 781178, 781196, 781296 Class III 2023-12-29 Achieva 1.5T Conversion, Model No. 781283 Class III 2023-12-29 Ingenia Ambition X, Model No. 782109 Class III 2023-12-29
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.