FDA action counts
| Total FDA actions | 205 |
|---|---|
| Warning letters | 0 |
| Recalls | 205 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | August 19, 2026 |
Enforcement history
On 2026-04-22, Argus HQ recorded a FDA recall for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., rated "high" severity in Argus HQ's classification: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medic… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-20, Argus HQ recorded a FDA recall for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., rated "high" severity in Argus HQ's classification: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221,… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-27, Argus HQ recorded a FDA recall for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., rated "high" severity in Argus HQ's classification: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063),… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-27, Argus HQ recorded a FDA recall for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., rated "high" severity in Argus HQ's classification: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Integris-Allura system; System Code Description (Model Numbers): Integris CV Ces… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-27, Argus HQ recorded a FDA recall for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., rated "high" severity in Argus HQ's classification: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura system; System Code Description (Model Numbers): Allura Xper FD10C (72200… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-27, Argus HQ recorded a FDA recall for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., rated "high" severity in Argus HQ's classification: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion systems not configured with an optional auxiliary pan handle. In… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-03, Argus HQ recorded a FDA recall for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., rated "high" severity in Argus HQ's classification: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-03, Argus HQ recorded a FDA recall for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., rated "high" severity in Argus HQ's classification: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063,… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-10, Argus HQ recorded a FDA recall for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., rated "high" severity in Argus HQ's classification: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 7B20/15, Model Numbers: 722068, 722226.
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 18 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.
Frequently asked questions
- Does Argus HQ track new FDA actions for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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 NEDERLAND B.V. is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.?
- 205 total: 0 warning letters, 205 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.?
- August 19, 2026. Argus HQ ingests new FDA enforcement records daily.
- Has PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. had product recalls?
- Yes, 205 recalls on file. See the full history below for each one.
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Related enforcement actions
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078,… →
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234,… →
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 7… →
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura under the following System Descriptions and corresponding model n… →
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interve… →
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion under the following System Descriptions and corresponding model… →
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032… →
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura… →
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.… →
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.… →
Compare with
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. vs Philips North America
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. vs Medline Industries, LP
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. vs Boston Scientific Corporation
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. vs Baxter Healthcare Corporation
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. vs Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Aug 19, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Regulatory Record: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/philips-medical-systems-nederland-b-v
"Regulatory Record: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/philips-medical-systems-nederland-b-v.
Argus HQ Research. "Regulatory Record: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.." Digital Empire Holdings LLC. Accessed August 29, 2026. https://argushq.ai/company/philips-medical-systems-nederland-b-v.
@misc{argushq_argushq_ai_company_philips_medical_systems_nederland_b_v_2026,
title = {Regulatory Record: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/company/philips-medical-systems-nederland-b-v},
note = {Accessed: August 29, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗