Has Philips Healthcare (Suzhou) Co., Ltd. had product recalls?

Yes, 2 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Philips Healthcare (Suzhou) Co., Ltd. official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Philips Healthcare (Suzhou) Co., Ltd. had?

Argus HQ has recorded 2 FDA events for Philips Healthcare (Suzhou) Co., Ltd.: 0 warning letters, 2 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Philips Healthcare (Suzhou) Co., Ltd.?

The most recent FDA event Argus HQ has on file for Philips Healthcare (Suzhou) Co., Ltd. is dated 2026-01-14, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Regulatory Record: Philips Healthcare (Suzhou) Co., Ltd.

FDA action counts

Total FDA actions	2
Warning letters	0
Recalls	2
Approval records	0
Form 483 inspection citations	0
Most recent action	January 14, 2026

The short version: Argus HQ has recorded 2 FDA events for Philips Healthcare (Suzhou) Co., Ltd.: 0 warning letters, 2 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2024-01-17 to 2026-01-14. The most severe rating Argus HQ has assigned across this history is "high". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Philips Healthcare (Suzhou) Co., Ltd. has 2 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Enforcement history

On 2026-01-14, Argus HQ recorded an FDA recall for Philips Healthcare (Suzhou) Co., Ltd., rated "high" severity in Argus HQ's classification: Philips Healthcare (Suzhou) Co., Ltd. — Class II recall: Philips Incisive CT. On 2024-01-17, Argus HQ recorded an FDA recall for Philips Healthcare (Suzhou) Co., Ltd., rated "high" severity in Argus HQ's classification: Philips Healthcare (Suzhou) Co., Ltd. — Class II recall: Incisive CT, model 728143 & 728144 running Software Version 5.0.0.. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Frequently asked questions

Has Philips Healthcare (Suzhou) Co., Ltd. had product recalls?: Yes, 2 recalls on file. See the full history below for each one.
Is this FDA enforcement data for Philips Healthcare (Suzhou) Co., Ltd. official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has Philips Healthcare (Suzhou) Co., Ltd. had?: Argus HQ has recorded 2 FDA events for Philips Healthcare (Suzhou) Co., Ltd.: 0 warning letters, 2 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
What is the most recent FDA action against Philips Healthcare (Suzhou) Co., Ltd.?: The most recent FDA event Argus HQ has on file for Philips Healthcare (Suzhou) Co., Ltd. is dated 2026-01-14, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Verified from FDA.gov · Last updated: Jan 14, 2026

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Regulatory Record: Philips Healthcare (Suzhou) Co., Ltd.. Digital Empire LLC. Retrieved from https://argushq.ai/company/philips-healthcare-suzhou-co-ltd

MLA

"Regulatory Record: Philips Healthcare (Suzhou) Co., Ltd.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/philips-healthcare-suzhou-co-ltd.

Chicago

Argus HQ Research. "Regulatory Record: Philips Healthcare (Suzhou) Co., Ltd.." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/company/philips-healthcare-suzhou-co-ltd.

BibTeX

@misc{argushq_argushq_ai_company_philips_healthcare_suzhou_co_ltd_2026,
  title = {Regulatory Record: Philips Healthcare (Suzhou) Co., Ltd.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/philips-healthcare-suzhou-co-ltd},
  note = {Accessed: July 17, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗