Countries where the notices were issued: United States (58).
Name as written in the notices: Philips North America; Philips North America Llc. This is the brand or the responsible company as each authority recorded it. A recall shows a safety system working; it is not a verdict on a brand. Follow the official notice for each product.
| Date | Authority | Product | Hazard (as classified) |
|---|
| 2026-08-28 | US FDA — Medical Devices | Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX) | — |
| 2026-08-28 | US FDA — Medical Devices | MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13; | — |
| 2026-08-28 | US FDA — Medical Devices | Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 | — |
| 2026-08-28 | US FDA — Medical Devices | Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1 | — |
| 2026-08-28 | US FDA — Medical Devices | Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13; | — |
| 2026-08-28 | US FDA — Medical Devices | MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13; | — |
| 2026-08-28 | US FDA — Medical Devices | SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13; | — |
| 2026-08-28 | US FDA — Medical Devices | Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 | — |
| 2026-08-28 | US FDA — Medical Devices | Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 | — |
| 2026-08-28 | US FDA — Medical Devices | Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S | — |
| 2026-08-28 | US FDA — Medical Devices | Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13; | — |
| 2026-08-28 | US FDA — Medical Devices | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to In | — |
| 2026-04-14 | US FDA — Medical Devices | Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145. | — |
| 2026-04-14 | US FDA — Medical Devices | Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Numbe | — |
| 2026-04-14 | US FDA — Medical Devices | Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. | — |
| 2026-04-14 | US FDA — Medical Devices | Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): | — |
| 2026-04-14 | US FDA — Medical Devices | Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782 | — |
| 2026-04-14 | US FDA — Medical Devices | Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296. | — |
| 2026-04-14 | US FDA — Medical Devices | Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262. | — |
| 2026-04-14 | US FDA — Medical Devices | Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 7821 | — |
| 2026-04-14 | US FDA — Medical Devices | Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105 | — |
| 2026-04-14 | US FDA — Medical Devices | Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178. | — |
| 2026-04-14 | US FDA — Medical Devices | Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. | — |
| 2026-04-14 | US FDA — Medical Devices | Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153. | — |
| 2026-01-07 | US FDA — Medical Devices | Brilliance iCT; Product Code (REF): 728306; | — |
| 2026-01-07 | US FDA — Medical Devices | Spectral CT; Product Code (REF): 728333; | — |
| 2026-01-07 | US FDA — Medical Devices | IQon Spectral CT; Product Code (REF): 728332; | — |
| 2025-10-29 | US FDA — Medical Devices | CT 5300; Software Version Number: 4.5, 5.0, 5.1; | — |
| 2025-10-29 | US FDA — Medical Devices | Incisive CT; Software Version Number: 4.5, 5.0, 5.1; | — |
| 2025-10-27 | US FDA — Medical Devices | Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM | — |
| 2025-05-29 | US FDA — Medical Devices | Intera 1.5T Achieva Nova-Dual Product Number: 781173; | — |
| 2025-05-29 | US FDA — Medical Devices | Intera 1.5T Explorer/Nova Dual Product Number: 781108; | — |
| 2025-05-29 | US FDA — Medical Devices | SmartPath to dStream for 1.5T; Product Number: 782146; | — |
| 2025-05-29 | US FDA — Medical Devices | Intera 1.5T Achieva IT Nova Product Number: 781175 | — |
| 2024-11-20 | US FDA — Medical Devices | Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216 | — |
| 2024-11-16 | US FDA — Medical Devices | Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344. | — |
| 2024-09-03 | US FDA — Medical Devices | Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of t | — |
| 2024-09-03 | US FDA — Medical Devices | Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectr | — |
| 2024-09-03 | US FDA — Medical Devices | Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra o | — |
| 2024-09-03 | US FDA — Medical Devices | Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or sp | — |
| 2024-09-03 | US FDA — Medical Devices | SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic im | — |
| 2024-09-03 | US FDA — Medical Devices | Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra | — |
| 2024-09-03 | US FDA — Medical Devices | SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images an | — |
| 2024-09-03 | US FDA — Medical Devices | Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectr | — |
| 2024-09-03 | US FDA — Medical Devices | Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of th | — |
| 2024-09-03 | US FDA — Medical Devices | SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images a | — |
| 2024-06-28 | US FDA — Medical Devices | IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicate | — |
| 2024-06-28 | US FDA — Medical Devices | IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicate | — |
| 2024-02-15 | US FDA — Medical Devices | DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD | — |
| 2024-01-03 | US FDA — Medical Devices | Intera 1.5T Achieva Nova. Model (REF) Numbers 781172. | — |
| 2024-01-03 | US FDA — Medical Devices | SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129. | — |
| 2024-01-03 | US FDA — Medical Devices | Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105. | — |
| 2024-01-03 | US FDA — Medical Devices | Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296. | — |
| 2024-01-03 | US FDA — Medical Devices | Achieva XR. Model (REF) Numbers 781153, 781253. | — |
| 2024-01-03 | US FDA — Medical Devices | Achieva 1.5T Initial system. Model (REF) Numbers 781178. | — |
| 2023-12-29 | US FDA — Medical Devices | Achieva 3.0T, Model No. 781177 | — |
| 2023-12-29 | US FDA — Medical Devices | SmartPath to dStream for 1.5T, Model No. 781260, 782112 | — |
| 2023-12-29 | US FDA — Medical Devices | Intera 1.5T, Model No. 781195 | — |