PlainRecalls

Philips North America

73 recalls on record · Latest: Feb 4, 2026

Philips North America Recall Insight

Philips North America appears on 73 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.087% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 4, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 3 critical, 46 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Jan 31, 2024 to Feb 4, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Feb 4, 2026

SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.

FDA Devices Moderate Feb 4, 2026

Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.

FDA Devices Moderate Feb 4, 2026

Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.

FDA Devices Moderate Feb 4, 2026

Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.

FDA Devices Moderate Feb 4, 2026

MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.

FDA Devices Moderate Feb 4, 2026

Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.

FDA Devices Moderate Feb 4, 2026

Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.

FDA Devices Moderate Feb 4, 2026

Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.

FDA Devices Moderate Feb 4, 2026

SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.

FDA Devices Moderate Feb 4, 2026

Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.

FDA Devices Moderate Feb 4, 2026

Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.

FDA Devices Moderate Feb 4, 2026

Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.

FDA Devices Moderate Dec 17, 2025

Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

FDA Devices Moderate Oct 22, 2025

Cardiac Workstation 5000; Model Number: 860439;

FDA Devices Moderate Aug 6, 2025

Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);

FDA Devices Moderate Aug 6, 2025

SmartPath to dStream for 3.0T Model Number (REF): 782145;

FDA Devices Moderate Aug 6, 2025

Ingenia 1.5T S Model Number (REF): 781347;

FDA Devices Moderate Aug 6, 2025

Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;

FDA Devices Moderate Aug 6, 2025

MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;

FDA Devices Moderate Aug 6, 2025

Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;

FDA Devices Moderate Aug 6, 2025

Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;

FDA Devices Moderate Aug 6, 2025

Upgrade to MR 7700 Model Number (REF): 782130;

FDA Devices Moderate Aug 6, 2025

Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;

FDA Devices Moderate Aug 6, 2025

Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);

FDA Devices Moderate Aug 6, 2025

Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;

FDA Devices Moderate Aug 6, 2025

SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;

FDA Devices Moderate Aug 6, 2025

Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;

FDA Devices Moderate Aug 6, 2025

Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;

FDA Devices Moderate Aug 6, 2025

Intera 3.0T Quasar Dual Model Number (REF): 781150;

FDA Devices Moderate Jun 18, 2025

Intera 1.5T Achieva Nova-Dual Product Number: 781173;

FDA Devices Moderate Jun 18, 2025

Intera 1.5T Explorer/Nova Dual Product Number: 781108;

FDA Devices Moderate Jun 18, 2025

SmartPath to dStream for 1.5T¿; Product Number: 782146;

FDA Devices Moderate Jun 18, 2025

Intera 1.5T Achieva IT Nova Product Number: 781175

FDA Devices Moderate Oct 16, 2024

Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

FDA Devices Moderate Apr 3, 2024

CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X

FDA Devices Moderate Apr 3, 2024

Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X

FDA Devices Moderate Feb 21, 2024

ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150

FDA Devices Moderate Feb 21, 2024

ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110

FDA Devices Critical Feb 14, 2024

BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4…

FDA Devices Moderate Feb 14, 2024

Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

FDA Devices Critical Feb 14, 2024

BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161

FDA Devices Moderate Feb 14, 2024

Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

FDA Devices Critical Feb 14, 2024

BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;

FDA Devices Moderate Feb 7, 2024

Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.

FDA Devices Moderate Feb 7, 2024

SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.

FDA Devices Moderate Feb 7, 2024

Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.

FDA Devices Moderate Feb 7, 2024

Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.

FDA Devices Moderate Feb 7, 2024

Achieva XR. Model (REF) Numbers 781153, 781253.

FDA Devices Moderate Feb 7, 2024

Achieva 1.5T Initial system. Model (REF) Numbers 781178.

FDA Devices Low Jan 31, 2024

Achieva 3.0T, Model No. 781177

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Philips North America with FORD →

Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds