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fda_recall · device_recall · high

Philips North America — Class II recall: Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;

Event date
2025-08-06 00:00:00Z
Observed
2026-07-16 23:20:10Z
Source ID
Z-2207-2025
Payload hash
1ead3c65792d70c80ec50e6e…

Summary

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Status: Ongoing.

Entities

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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 2025-08-06; 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 North America — Class II recall: Ingenia 3.0T CX  Model Numbers (REF): (1) 781271, (2) 782105;. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-north-america-z-2207-2025
MLA
"Philips North America — Class II recall: Ingenia 3.0T CX  Model Numbers (REF): (1) 781271, (2) 782105;." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/events/fda-recall-philips-north-america-z-2207-2025.
Chicago
Argus HQ Research. "Philips North America — Class II recall: Ingenia 3.0T CX  Model Numbers (REF): (1) 781271, (2) 782105;." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-north-america-z-2207-2025.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_philips_north_america_z_2207_2025_2025,
  title = {Philips North America — Class II recall: Ingenia 3.0T CX  Model Numbers (REF): (1) 781271, (2) 782105;},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-north-america-z-2207-2025},
  note = {Accessed: July 17, 2026}
}

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

Philips North America — Class II recall: Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105; · Argus HQ