Philips North America Llc'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 North America Llc has 4 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.

Enforcement history

On 2026-06-17, Argus HQ recorded a FDA recall for Philips North America Llc, rated "high" severity in Argus HQ's classification: Philips North America Llc — Class II recall: DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Philips North America Llc, rated "high" severity in Argus HQ's classification: Philips North America Llc — Class II recall: Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Philips North America Llc, rated "high" severity in Argus HQ's classification: Philips North America Llc — Class II recall: Philips Avalon Fetal Monitor, FM 30 Part numberM2703A An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Philips North America Llc, rated "high" severity in Argus HQ's classification: Philips North America Llc — Class II recall: Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the follo… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Philips North America Llc has 4 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations).

Frequently asked questions

What is the most recent FDA action on file for Philips North America Llc?

July 1, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Philips North America Llc had product recalls?

Yes, 4 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Philips North America Llc 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 Llc had?

Argus HQ has recorded 4 FDA events for Philips North America Llc: 0 warning letters, 4 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 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. →

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