PHILIPS MEDICAL SYSTEMS's Complete FDA Record

FDA action counts

Enforcement history

On 2026-04-22, Argus HQ recorded an FDA recall for PHILIPS MEDICAL SYSTEMS, rated "high" severity in Argus HQ's classification: PHILIPS MEDICAL SYSTEMS — Class II recall: Philips Spectral CT on Rails. Model Number: 728334.. 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 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 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 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.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. PHILIPS MEDICAL SYSTEMS has 1 FDA event on file. 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. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Frequently asked questions

How many FDA actions does Argus HQ track for PHILIPS MEDICAL SYSTEMS?

11 total: 0 warning letters, 11 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for PHILIPS MEDICAL SYSTEMS?

August 5, 2026. Argus HQ ingests new FDA enforcement records daily.

Has PHILIPS MEDICAL SYSTEMS had product recalls?

Yes, 11 recalls on file. See the full history below for each one.

Is this FDA enforcement data for PHILIPS MEDICAL SYSTEMS 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.

Related enforcement actions

• PHILIPS MEDICAL SYSTEMS — Class II recall: Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Ch… →
• PHILIPS MEDICAL SYSTEMS — Class II recall: IQon Spectral CT IQon Spectral CT Upgrades →
• PHILIPS MEDICAL SYSTEMS — Class II recall: Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Prem… →
• PHILIPS MEDICAL SYSTEMS — Class II recall: Philips Spectral CT on Rails. Model Number: 728334. →
• PHILIPS MEDICAL SYSTEMS — Class II recall: Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1… →
• PHILIPS MEDICAL SYSTEMS — Class II recall: Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versi… →
• PHILIPS MEDICAL SYSTEMS — Class II recall: Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versio… →
• PHILIPS MEDICAL SYSTEMS — Class II recall: CombiDiagnost R90 1.0 (709030) →
• PHILIPS MEDICAL SYSTEMS — Class II recall: CombiDiagnost R90 1.1 (709031) →
• PHILIPS MEDICAL SYSTEMS — Class II recall: Spectral CT on Rails: Software Version 5.1.0.X, model 728334. →

Compare with

• PHILIPS MEDICAL SYSTEMS vs Philips North America
• PHILIPS MEDICAL SYSTEMS vs Medline Industries, LP
• PHILIPS MEDICAL SYSTEMS vs Boston Scientific Corporation
• PHILIPS MEDICAL SYSTEMS vs Baxter Healthcare Corporation
• PHILIPS MEDICAL SYSTEMS vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.