Philips North America — FDA Enforcement History

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Philips North America has 19 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.

Enforcement history

On 2026-05-06, Argus HQ recorded a FDA recall for Philips North America, rated "high" severity in Argus HQ's classification: Philips North America — Class II recall: Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model N… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Philips North America, rated "high" severity in Argus HQ's classification: Philips North America — Class II recall: Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Num… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Philips North America, rated "high" severity in Argus HQ's classification: Philips North America — Class II recall: Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120.… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Philips North America, rated "high" severity in Argus HQ's classification: Philips North America — Class II recall: Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7813… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Philips North America, rated "high" severity in Argus HQ's classification: Philips North America — Class II recall: Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Philips North America, rated "high" severity in Argus HQ's classification: Philips North America — Class II recall: Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF)… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Philips North America, rated "high" severity in Argus HQ's classification: Philips North America — Class II recall: Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7811… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Philips North America, rated "high" severity in Argus HQ's classification: Philips North America — Class II recall: Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7813… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Philips North America, rated "high" severity in Argus HQ's classification: Philips North America — Class II recall: Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA.

Frequently asked questions

Has Philips North America had product recalls?

Yes, 355 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Philips North America official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Philips North America had?

Argus HQ has recorded 19 FDA events for Philips North America: 0 warning letters, 19 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Philips North America?

The most recent FDA event Argus HQ has on file for Philips North America is dated 2026-05-06, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Related enforcement actions

• Philips North America Llc — Class II recall: Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the follo… →
• Philips North America Llc — Class II recall: Philips Avalon Fetal Monitor, FM 30 Part numberM2703A →
• Philips North America Llc — Class II recall: Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A →
• Philips North America Llc — Class II recall: DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. →
• Philips North America — Class II recall: Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (… →
• Philips North America — Class II recall: Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (… →
• Philips North America — Class II recall: Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model N… →
• Philips North America — Class II recall: Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF)… →
• Philips North America — Class II recall: Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model N… →
• Philips North America — Class II recall: Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model… →

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