Philips North America

Complete recall history across all FDA and CPSC categories — 107 total recalls

Philips North America appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (107)

FDA medical device enforcement actions by Philips North America. Showing most recent 50.

Date Product Reason Class
Apr 14, 2026 Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Mode... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). ... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (R... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (R... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (RE... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Numbe... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model ... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF)... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (RE... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF)... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (R... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Numbe... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Mod... The potential for stiffness value errors when a specific range of image recon... Class II
Apr 14, 2026 Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Mode... The potential for stiffness value errors when a specific range of image recon... Class II
Dec 22, 2025 Patient Information Center iX; Software Version Number: 4.5.0 A recent software (SW) patch modifies Mobile Event Notification filter settin... Class II
Dec 3, 2025 Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with... The potential for stiffness value errors when viewing exported MR Elastograph... Class II
Dec 3, 2025 Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW versio... The potential for stiffness value errors when viewing exported MR Elastograph... Class II
Dec 3, 2025 Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. ... The potential for stiffness value errors when viewing exported MR Elastograph... Class II
Dec 3, 2025 Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. ... The potential for stiffness value errors when viewing exported MR Elastograph... Class II
Dec 3, 2025 SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR syst... The potential for stiffness value errors when viewing exported MR Elastograph... Class II
Dec 3, 2025 Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW ve... The potential for stiffness value errors when viewing exported MR Elastograph... Class II
Dec 3, 2025 Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. ... The potential for stiffness value errors when viewing exported MR Elastograph... Class II
Dec 3, 2025 Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R... The potential for stiffness value errors when viewing exported MR Elastograph... Class II
Dec 3, 2025 MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW v... The potential for stiffness value errors when viewing exported MR Elastograph... Class II
Dec 3, 2025 Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with... The potential for stiffness value errors when viewing exported MR Elastograph... Class II
Dec 3, 2025 Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR s... The potential for stiffness value errors when viewing exported MR Elastograph... Class II
Dec 3, 2025 Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW versio... The potential for stiffness value errors when viewing exported MR Elastograph... Class II
Dec 3, 2025 SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems wit... The potential for stiffness value errors when viewing exported MR Elastograph... Class II
Oct 27, 2025 Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVE... Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm ... Class II
Sep 12, 2025 Cardiac Workstation 7000; Model Number: 860441; Failure of Environmental Stress Testing from a pinched power module wire with... Class II
Sep 12, 2025 Cardiac Workstation 5000; Model Number: 860439; Failure of Environmental Stress Testing from a pinched power module wire with... Class II
Jun 30, 2025 Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; The potential for component failures in the Gradient Coil of the affected MR ... Class II
Jun 30, 2025 MR 7700 Model Numbers (REF): (1) 782120, (2) 782153; The potential for component failures in the Gradient Coil of the affected MR ... Class II
Jun 30, 2025 SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 78... The potential for component failures in the Gradient Coil of the affected MR ... Class II
Jun 30, 2025 Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 78... The potential for component failures in the Gradient Coil of the affected MR ... Class II
Jun 30, 2025 Intera 3.0T Quasar Dual Model Number (REF): 781150; The potential for component failures in the Gradient Coil of the affected MR ... Class II
Jun 30, 2025 Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148; The potential for component failures in the Gradient Coil of the affected MR ... Class II
Jun 30, 2025 Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143; The potential for component failures in the Gradient Coil of the affected MR ... Class II
Jun 30, 2025 SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144; The potential for component failures in the Gradient Coil of the affected MR ... Class II
Jun 30, 2025 Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253; The potential for component failures in the Gradient Coil of the affected MR ... Class II
Jun 30, 2025 Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (... The potential for component failures in the Gradient Coil of the affected MR ... Class II
Jun 30, 2025 Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105; The potential for component failures in the Gradient Coil of the affected MR ... Class II
Jun 30, 2025 Upgrade to MR 7700 Model Number (REF): 782130; The potential for component failures in the Gradient Coil of the affected MR ... Class II
Jun 30, 2025 Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) ... The potential for component failures in the Gradient Coil of the affected MR ... Class II
Jun 30, 2025 Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (... The potential for component failures in the Gradient Coil of the affected MR ... Class II

View all 107 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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