Philips Medical Systems (Cleveland) Inc's Complete FDA Record

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Philips Medical Systems (Cleveland) Inc has 2 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. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Enforcement history

On 2025-09-24, Argus HQ recorded an FDA recall for Philips Medical Systems (Cleveland) Inc, rated "high" severity in Argus HQ's classification: Philips Medical Systems (Cleveland) Inc — Class II recall: Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspac…. On 2025-08-13, Argus HQ recorded an FDA recall for Philips Medical Systems (Cleveland) Inc, rated "high" severity in Argus HQ's classification: Philips Medical Systems (Cleveland) Inc — Class II recall: Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software. 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.

Frequently asked questions

What is the most recent FDA action on file for Philips Medical Systems (Cleveland) Inc?

September 24, 2025. Argus HQ ingests new FDA enforcement records daily.

Has Philips Medical Systems (Cleveland) Inc had product recalls?

Yes, 2 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Philips Medical Systems (Cleveland) Inc 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 Medical Systems (Cleveland) Inc had?

Argus HQ has recorded 2 FDA events for Philips Medical Systems (Cleveland) Inc: 0 warning letters, 2 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.

Related enforcement actions

• Philips Medical Systems (Cleveland) Inc — Class II recall: Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspac… →
• Philips Medical Systems (Cleveland) Inc — Class II recall: Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software →

Compare with

• Philips Medical Systems (Cleveland) Inc vs Philips North America
• Philips Medical Systems (Cleveland) Inc vs Boston Scientific Corporation
• Philips Medical Systems (Cleveland) Inc vs Medline Industries, LP
• Philips Medical Systems (Cleveland) Inc vs Baxter Healthcare Corporation
• Philips Medical Systems (Cleveland) Inc vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.