Has PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. had other FDA enforcement actions?

Yes. Argus HQ has recorded 199 total FDA actions tied to PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 0 warning letters, 199 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2024-12-18; Argus observed and indexed it on 2026-07-16.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura…

Name: FDA Recall Record — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Creator: Argus HQ
Published: 2024-12-18
License: https://argushq.ai/methodology

Event date: 2024-12-18 00:00:00Z
Observed: 2026-07-16 23:20:11Z
Source ID: Z-0676-2025
Payload hash: bd42dcab78b4cf84bdf326e8…

Summary

Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt a… Status: Ongoing.

Entities

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

View source record ↗

Frequently asked questions

Has PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. had other FDA enforcement actions?: Yes. Argus HQ has recorded 199 total FDA actions tied to PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 0 warning letters, 199 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2024-12-18; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2024). PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following:     1. Allura…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-0676-2025

MLA

"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following:     1. Allura…." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-0676-2025.

Chicago

Argus HQ Research. "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following:     1. Allura…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-0676-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_medical_systems_nederland_b_v_z_0676_2025_2024,
  title = {PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following:     1. Allura…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-0676-2025},
  note = {Accessed: July 17, 2026}
}

Informational only. Not legal, financial, or medical advice.