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fda_recall · device_recall · high

Philips North America Llc — Class II recall: DigitalDiagnost C50 1.1-intended for use in generating radiographic images of hu…

Event date
2023-04-19 00:00:00Z
Observed
2026-07-16 23:20:13Z
Source ID
Z-1383-2023
Payload hash
775ebe1bf697e419ca511e29

Summary

If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension… Status: Ongoing.

Frequently asked questions

Has Philips North America had other FDA enforcement actions?
Yes. Argus HQ has recorded 355 total FDA actions tied to Philips North America: 0 warning letters, 355 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 2023-04-19; 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 (2023). Philips North America Llc — Class II recall: DigitalDiagnost C50 1.1-intended for use in generating radiographic images of hu…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-north-america-llc-z-1383-2023
MLA
"Philips North America Llc — Class II recall: DigitalDiagnost C50 1.1-intended for use in generating radiographic images of hu…." Argus HQ Research, Digital Empire LLC, 2023, argushq.ai/events/fda-recall-philips-north-america-llc-z-1383-2023.
Chicago
Argus HQ Research. "Philips North America Llc — Class II recall: DigitalDiagnost C50 1.1-intended for use in generating radiographic images of hu…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-north-america-llc-z-1383-2023.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_philips_north_america_llc_z_1383_2023_2023,
  title = {Philips North America Llc — Class II recall: DigitalDiagnost C50 1.1-intended for use in generating radiographic images of hu…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-north-america-llc-z-1383-2023},
  note = {Accessed: July 17, 2026}
}

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