PlainRecalls

Philips North America

Compiled from official public sources by the editorial team.

126 recalls on record · Latest: May 6, 2026

Philips North America Recall Insight

Philips North America appears on 126 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.124% 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 May 6, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 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 Aug 6, 2025 to May 6, 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 May 6, 2026

Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

FDA Devices Moderate May 6, 2026

Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Mode…

FDA Devices Moderate May 6, 2026

Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782…

FDA Devices Moderate May 6, 2026

Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.

FDA Devices Moderate May 6, 2026

Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF…

FDA Devices Moderate May 6, 2026

Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.

FDA Devices Moderate May 6, 2026

Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.

FDA Devices Moderate May 6, 2026

Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF)…

FDA Devices Moderate May 6, 2026

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K1730…

FDA Devices Moderate May 6, 2026

Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.

FDA Devices Moderate May 6, 2026

Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781…

FDA Devices Moderate May 6, 2026

Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.

FDA Devices Moderate May 6, 2026

Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.

FDA Devices Moderate May 6, 2026

Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (R…

FDA Devices Moderate May 6, 2026

Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF)…

FDA Devices Moderate May 6, 2026

Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.

FDA Devices Moderate May 6, 2026

Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF…

FDA Devices Moderate May 6, 2026

Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.

FDA Devices Moderate May 6, 2026

Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.

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 Feb 4, 2026

Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.

FDA Devices Moderate Jan 28, 2026

Patient Information Center iX; Software Version Number: 4.5.0

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 Oct 22, 2025

Cardiac Workstation 7000; Model Number: 860441;

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;

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Philips North America with Zimmer Biomet, Inc. →

Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.