Brand

Philips North America Recalls

82 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Philips North America.

82Total Recalls
20Critical
269,405Units Affected
Apr 14, 2026Most Recent
All Recalls

Every Philips North America Recall

Sorted by most recent. Click any recall for full details.

82 recalls
High RiskFDA
Philips North America
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Medical Devices·1 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. ...
Medical Devices·3 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Numbe...
Medical Devices·64 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.
Medical Devices·3 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model...
Medical Devices·7 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
Medical Devices·3 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Medical Devices·1 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model ...
Medical Devices·103 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Nu...
Medical Devices·22 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Medical Devices·1 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Numbe...
Medical Devices·54 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
Medical Devices·25 affected·Apr 14, 2026
High RiskFDA
Philips North America
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
Medical Devices·1 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Medical Devices·1 affected·Dec 3, 2025
High RiskFDA
Philips North America
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Medical Devices·3 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Medical Devices·24 affected·Dec 3, 2025
High RiskFDA
Philips North America
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
Medical Devices·9 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Medical Devices·6 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
Medical Devices·31 affected·Dec 3, 2025
High RiskFDA
Philips North America
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Medical Devices·1 affected·Dec 3, 2025
High RiskFDA
Philips North America
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
Medical Devices·3 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
Medical Devices·21 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
Medical Devices·5 affected·Dec 3, 2025
High RiskFDA
Philips North America
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
Medical Devices·6 affected·Dec 3, 2025
High RiskFDA
Philips North America
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Medical Devices·110 affected·Oct 27, 2025
High RiskFDA
Philips North America
Cardiac Workstation 5000; Model Number: 860439;
Cardiac Devices·28 affected·Sep 12, 2025
CriticalFDA
Philips North America
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
Medical Devices·632 affected·Jun 30, 2025
CriticalFDA
Philips North America
SmartPath to dStream for 3.0T Model Number (REF): 782145;
Medical Devices·15 affected·Jun 30, 2025
CriticalFDA
Philips North America
Ingenia 1.5T S Model Number (REF): 781347;
Medical Devices·136 affected·Jun 30, 2025
CriticalFDA
Philips North America
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
Medical Devices·1,467 affected·Jun 30, 2025
CriticalFDA
Philips North America
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
Medical Devices·551 affected·Jun 30, 2025
CriticalFDA
Philips North America
Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
Medical Devices·611 affected·Jun 30, 2025
CriticalFDA
Philips North America
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
Medical Devices·460 affected·Jun 30, 2025
CriticalFDA
Philips North America
Upgrade to MR 7700 Model Number (REF): 782130;
Medical Devices·26 affected·Jun 30, 2025
CriticalFDA
Philips North America
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
Medical Devices·350 affected·Jun 30, 2025
CriticalFDA
Philips North America
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Medical Devices·242 affected·Jun 30, 2025
CriticalFDA
Philips North America
Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
Medical Devices·40 affected·Jun 30, 2025
CriticalFDA
Philips North America
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
Medical Devices·33 affected·Jun 30, 2025
CriticalFDA
Philips North America
Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
Medical Devices·50 affected·Jun 30, 2025
CriticalFDA
Philips North America
Intera 1.5T Achieva Nova-Dual Product Number: 781173;
Medical Devices·3 affected·May 29, 2025
CriticalFDA
Philips North America
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Medical Devices·1 affected·May 29, 2025
CriticalFDA
Philips North America
SmartPath to dStream for 1.5T¿; Product Number: 782146;
Medical Devices·1 affected·May 29, 2025
CriticalFDA
Philips North America
Intera 1.5T Achieva IT Nova Product Number: 781175
Medical Devices·1 affected·May 29, 2025
High RiskFDA
Philips North America
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
Medical Devices·2,323 affected·Feb 28, 2024
High RiskFDA
Philips North America
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Versi...
Medical Devices·257,183 affected·Feb 28, 2024
High RiskFDA
Philips North America
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
Medical Devices·12 affected·Jan 3, 2024
High RiskFDA
Philips North America
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
Medical Devices·21 affected·Jan 3, 2024
High RiskFDA
Philips North America
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
Medical Devices·1 affected·Jan 3, 2024