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fda_recall · device_recall · high

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280

Event date
2025-02-12 00:00:00Z
Observed
2026-07-16 23:20:11Z
Source ID
Z-1088-2025
Payload hash
bdeedec8e62ad2e40cc3b13c

Summary

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an… Status: Ongoing.

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 2025-02-12; 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 (2025). PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 3 M15  System Code:	  (1) 722064  (2)	722222  (3)	722280. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-1088-2025
MLA
"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 3 M15  System Code:	  (1) 722064  (2)	722222  (3)	722280." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-1088-2025.
Chicago
Argus HQ Research. "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 3 M15  System Code:	  (1) 722064  (2)	722222  (3)	722280." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-1088-2025.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_philips_medical_systems_nederland_b_v_z_1088_2025_2025,
  title = {PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 3 M15  System Code:	  (1) 722064  (2)	722222  (3)	722280},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-1088-2025},
  note = {Accessed: July 17, 2026}
}

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