Regulatory Record: Philips Medical Systems Technologies Ltd.

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 Technologies Ltd. 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.

Enforcement history

On 2024-11-27, Argus HQ recorded an FDA recall for Philips Medical Systems Technologies Ltd., rated "high" severity in Argus HQ's classification: Philips Medical Systems Technologies Ltd. — Class II recall: Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 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

How many FDA actions has Philips Medical Systems Technologies Ltd. had?

Argus HQ has recorded 1 FDA events for Philips Medical Systems Technologies Ltd.: 0 warning letters, 1 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 Medical Systems Technologies Ltd.?

The most recent FDA event Argus HQ has on file for Philips Medical Systems Technologies Ltd. is dated 2024-11-27, 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.

Does Argus HQ track new FDA actions for Philips Medical Systems Technologies Ltd. automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Philips Medical Systems Technologies Ltd. is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Philips Medical Systems Technologies Ltd.?

1 total: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Related enforcement actions

• Philips Medical Systems Technologies Ltd. — Class II recall: Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software… →

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