Has Philips Ultrasound, Inc had other FDA enforcement actions?

Yes. Argus HQ has recorded 105 total FDA actions tied to Philips Ultrasound, Inc: 0 warning letters, 105 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 2023-09-13; 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, Inc. — Class II recall: 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti…

Name: FDA Recall Record — Philips Ultrasound, Inc
Creator: Argus HQ
Published: 2023-09-13
License: https://argushq.ai/methodology

Event date: 2023-09-13 00:00:00Z
Observed: 2026-07-16 23:20:13Z
Source ID: Z-2517-2023
Payload hash: c096ee7336c04129c5e4b58b…

Summary

Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail. Status: Completed.

Entities

Philips Ultrasound, Inc

View source record ↗

Frequently asked questions

Has Philips Ultrasound, Inc had other FDA enforcement actions?: Yes. Argus HQ has recorded 105 total FDA actions tied to Philips Ultrasound, Inc: 0 warning letters, 105 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 2023-09-13; 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 Ultrasound, Inc. — Class II recall: 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-ultrasound-inc-z-2517-2023

MLA

"Philips Ultrasound, Inc. — Class II recall: 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti…." Argus HQ Research, Digital Empire LLC, 2023, argushq.ai/events/fda-recall-philips-ultrasound-inc-z-2517-2023.

Chicago

Argus HQ Research. "Philips Ultrasound, Inc. — Class II recall: 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-ultrasound-inc-z-2517-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_ultrasound_inc_z_2517_2023_2023,
  title = {Philips Ultrasound, Inc. — Class II recall: 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-ultrasound-inc-z-2517-2023},
  note = {Accessed: July 17, 2026}
}

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