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 2025-05-28; 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 North America Llc — Class II recall: Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 78…

Name: FDA Recall Record — Philips North America
Creator: Argus HQ
Published: 2025-05-28
License: https://argushq.ai/methodology

Event date: 2025-05-28 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-1801-2025
Payload hash: 73924f6ee68af98bd76d1168…

Summary

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Status: Ongoing.

Entities

Philips North America

View source record ↗

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 2025-05-28; 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 Llc — Class II recall: Product Name: Ingenia Ambition X;  Model Numbers: (1) 781356, (2) 782109, (3) 78…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-north-america-llc-z-1801-2025

MLA

"Philips North America Llc — Class II recall: Product Name: Ingenia Ambition X;  Model Numbers: (1) 781356, (2) 782109, (3) 78…." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/events/fda-recall-philips-north-america-llc-z-1801-2025.

Chicago

Argus HQ Research. "Philips North America Llc — Class II recall: Product Name: Ingenia Ambition X;  Model Numbers: (1) 781356, (2) 782109, (3) 78…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-north-america-llc-z-1801-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_north_america_llc_z_1801_2025_2025,
  title = {Philips North America Llc — Class II recall: Product Name: Ingenia Ambition X;  Model Numbers: (1) 781356, (2) 782109, (3) 78…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-north-america-llc-z-1801-2025},
  note = {Accessed: July 17, 2026}
}

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