Has Philips Healthcare had other FDA enforcement actions?

This is the only FDA action Argus HQ has on file for Philips Healthcare as of 2026-07-16. Argus ingests new FDA enforcement records daily.

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 2023-10-11; 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 Healthcare — Class II recall: Incisive CT, software version 5.0

Name: FDA Recall Record — Philips Healthcare
Creator: Argus HQ
Published: 2023-10-11
License: https://argushq.ai/methodology

Event date: 2023-10-11 00:00:00Z
Observed: 2026-07-16 23:20:13Z
Source ID: Z-2520-2023
Payload hash: 8019670e992e85e081907bd4…

Summary

Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area. Issue 3: A… Status: Ongoing.

Entities

Philips Healthcare

View source record ↗

Frequently asked questions

Has Philips Healthcare had other FDA enforcement actions?: This is the only FDA action Argus HQ has on file for Philips Healthcare as of 2026-07-16. Argus ingests new FDA enforcement records daily.
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 2023-10-11; 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 Healthcare — Class II recall: Incisive CT, software version 5.0. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-healthcare-z-2520-2023

MLA

"Philips Healthcare — Class II recall: Incisive CT, software version 5.0." Argus HQ Research, Digital Empire LLC, 2023, argushq.ai/events/fda-recall-philips-healthcare-z-2520-2023.

Chicago

Argus HQ Research. "Philips Healthcare — Class II recall: Incisive CT, software version 5.0." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-healthcare-z-2520-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_healthcare_z_2520_2023_2023,
  title = {Philips Healthcare — Class II recall: Incisive CT, software version 5.0},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-healthcare-z-2520-2023},
  note = {Accessed: July 17, 2026}
}

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