Has Philips Healthcare (Suzhou) Co., Ltd. had other FDA enforcement actions?

Yes. Argus HQ has recorded 2 total FDA actions tied to Philips Healthcare (Suzhou) Co., Ltd.: 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 2024-01-17; 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 (Suzhou) Co., Ltd. — Class II recall: Incisive CT, model 728143 & 728144 running Software Version 5.0.0.

Name: FDA Recall Record — Philips Healthcare (Suzhou) Co., Ltd.
Creator: Argus HQ
Published: 2024-01-17
License: https://argushq.ai/methodology

Event date: 2024-01-17 00:00:00Z
Observed: 2026-07-16 23:20:13Z
Source ID: Z-0640-2024
Payload hash: 15162d8ab21e3379e47e22b1…

Summary

Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work… Status: Ongoing.

Entities

Philips Healthcare (Suzhou) Co., Ltd.

View source record ↗

Frequently asked questions

Has Philips Healthcare (Suzhou) Co., Ltd. had other FDA enforcement actions?: Yes. Argus HQ has recorded 2 total FDA actions tied to Philips Healthcare (Suzhou) Co., Ltd.: 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 2024-01-17; 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 (2024). Philips Healthcare (Suzhou) Co., Ltd. — Class II recall: Incisive CT, model 728143 & 728144 running Software Version 5.0.0.. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-healthcare-suzhou-co-ltd-z-0640-2024

MLA

"Philips Healthcare (Suzhou) Co., Ltd. — Class II recall: Incisive CT, model 728143 & 728144 running Software Version 5.0.0.." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-philips-healthcare-suzhou-co-ltd-z-0640-2024.

Chicago

Argus HQ Research. "Philips Healthcare (Suzhou) Co., Ltd. — Class II recall: Incisive CT, model 728143 & 728144 running Software Version 5.0.0.." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-healthcare-suzhou-co-ltd-z-0640-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_healthcare_suzhou_co_ltd_z_0640_2024_2024,
  title = {Philips Healthcare (Suzhou) Co., Ltd. — Class II recall: Incisive CT, model 728143 & 728144 running Software Version 5.0.0.},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-healthcare-suzhou-co-ltd-z-0640-2024},
  note = {Accessed: July 17, 2026}
}

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