Has Philips Ultrasound, LLC had other FDA enforcement actions?

Yes. Argus HQ has recorded 2 total FDA actions tied to Philips Ultrasound, LLC: 0 warning letters, 2 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 2025-12-10; 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 Ultrasound, LLC — Class II recall: Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

Name: FDA Recall Record — Philips Ultrasound, LLC
Creator: Argus HQ
Published: 2025-12-10
License: https://argushq.ai/methodology

Event date: 2025-12-10 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-0883-2026
Payload hash: 8b0e911f1ba9e0f21a94d981…

Summary

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining. Status: Ongoing.

Entities

Philips Ultrasound, LLC

View source record ↗

Frequently asked questions

Has Philips Ultrasound, LLC had other FDA enforcement actions?: Yes. Argus HQ has recorded 2 total FDA actions tied to Philips Ultrasound, LLC: 0 warning letters, 2 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 2025-12-10; 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 Ultrasound, LLC — Class II recall: Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-ultrasound-llc-z-0883-2026

MLA

"Philips Ultrasound, LLC — Class II recall: Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/events/fda-recall-philips-ultrasound-llc-z-0883-2026.

Chicago

Argus HQ Research. "Philips Ultrasound, LLC — Class II recall: Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-ultrasound-llc-z-0883-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_ultrasound_llc_z_0883_2026_2025,
  title = {Philips Ultrasound, LLC — Class II recall: Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-ultrasound-llc-z-0883-2026},
  note = {Accessed: July 17, 2026}
}

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