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 2023-01-18; 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: Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate…

Name: FDA Recall Record — Philips North America
Creator: Argus HQ
Published: 2023-01-18
License: https://argushq.ai/methodology

Event date: 2023-01-18 00:00:00Z
Observed: 2026-07-16 23:20:13Z
Source ID: Z-0908-2023
Payload hash: 0567bae3e02e116de83db4ff…

Summary

Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product. 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 2023-01-18; 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: Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-north-america-llc-z-0908-2023

MLA

"Philips North America Llc — Class II recall: Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate…." Argus HQ Research, Digital Empire LLC, 2023, argushq.ai/events/fda-recall-philips-north-america-llc-z-0908-2023.

Chicago

Argus HQ Research. "Philips North America Llc — Class II recall: Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-north-america-llc-z-0908-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_north_america_llc_z_0908_2023_2023,
  title = {Philips North America Llc — Class II recall: Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-north-america-llc-z-0908-2023},
  note = {Accessed: July 17, 2026}
}

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