PlainRecalls

Philips North America

126 recalls on record · Latest: May 6, 2026

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Agency notice ledger

Federal filing book Philips North America HEAVY-BOOK · SINGLE-AGENCY

#127 of 14,151 · 126 notices · 0.121% archive

  • BOOK 126 notices
  • RANK #127 of 14,151
  • SHARE 0.121% archive
  • AGENCY FDA Devices (126)
  • CAT medical devices
  • CATS 1 category
  • LATEST May 6, 2026
  • PHOTO Roche Diagnostics Ope…

Nearest notice-volume peer: Roche Diagnostics Operations, Inc. (1 notice gap)

Philips North America accounts for about 0.121% of the 104,423-notice archive on 126 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Philips North America compares to 14,151 recalling firms

Philips North America ranks 127th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Philips North America vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

126 127th of 14151 higher than 14,024 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Philips North America in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Philips North America holds about 0.121% of archive notices alongside 126 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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. Model Number (REF): 782163.

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): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

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): 782139.

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): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

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: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

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): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

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 (REF): 782166.

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): 782137.

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): 782138. 4. Model Number (REF): 782160.

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;

Philips North America carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (126 here — heavy-book).

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Frequently Asked Questions

How many federal recall notices name Philips North America?
PlainRecalls indexes 126 distinct federal recall events naming Philips North America, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Philips North America sit among other recalling firms?
Philips North America ranks #127 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Philips North America's notices?
FDA Devices accounts for 126 of this firm's 126 indexed notices.
What product category dominates Philips North America's filing book?
Filings for Philips North America span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous?
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Philips North America: 126 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Philips North America; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026