FDA action counts
| Total FDA actions | 1 |
|---|---|
| Warning letters | 0 |
| Recalls | 1 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | June 10, 2026 |
Enforcement history
On 2026-06-10, Argus HQ recorded an FDA recall for GE Medical Systems China Co., Ltd., rated "high" severity in Argus HQ's classification: GE Medical Systems China Co., Ltd. — Class II recall: MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis…. 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.
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. GE Medical Systems China Co., Ltd. has 1 FDA event on file. 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.
Frequently asked questions
- How many FDA actions does Argus HQ track for GE Medical Systems China Co., Ltd.?
- 1 total: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for GE Medical Systems China Co., Ltd.?
- June 10, 2026. Argus HQ ingests new FDA enforcement records daily.
- Has GE Medical Systems China Co., Ltd. had product recalls?
- Yes, 1 recall on file. See the full history below for each one.
- Is this FDA enforcement data for GE Medical Systems China 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.
Every FDA action tied to this company, the week it happens.
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Related enforcement actions
Compare with
- GE Medical Systems China Co., Ltd. vs Philips North America
- GE Medical Systems China Co., Ltd. vs Medline Industries, LP
- GE Medical Systems China Co., Ltd. vs Boston Scientific Corporation
- GE Medical Systems China Co., Ltd. vs Baxter Healthcare Corporation
- GE Medical Systems China Co., Ltd. vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Jun 10, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Enforcement History: GE Medical Systems China Co., Ltd.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/ge-medical-systems-china-co-ltd
"FDA Enforcement History: GE Medical Systems China Co., Ltd.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/ge-medical-systems-china-co-ltd.
Argus HQ Research. "FDA Enforcement History: GE Medical Systems China Co., Ltd.." Digital Empire Holdings LLC. Accessed August 29, 2026. https://argushq.ai/company/ge-medical-systems-china-co-ltd.
@misc{argushq_argushq_ai_company_ge_medical_systems_china_co_ltd_2026,
title = {FDA Enforcement History: GE Medical Systems China Co., Ltd.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/company/ge-medical-systems-china-co-ltd},
note = {Accessed: August 29, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗