FDA action counts
| Total FDA actions | 12 |
|---|---|
| Warning letters | 0 |
| Recalls | 12 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | October 7, 2026 |
Enforcement history
On 2026-10-07, Argus HQ recorded an FDA recall for Shanghai United Imaging Healthcare Co., Ltd., rated "high" severity in Argus HQ's classification: Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT ATLAS Astound with software. On 2026-10-07, Argus HQ recorded an FDA recall for Shanghai United Imaging Healthcare Co., Ltd., rated "high" severity in Argus HQ's classification: Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama…. On 2026-10-07, Argus HQ recorded an FDA recall for Shanghai United Imaging Healthcare Co., Ltd., rated "high" severity in Argus HQ's classification: Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT 550 with software. On 2026-10-07, Argus HQ recorded an FDA recall for Shanghai United Imaging Healthcare Co., Ltd., rated "high" severity in Argus HQ's classification: Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo…. On 2026-10-07, Argus HQ recorded an FDA recall for Shanghai United Imaging Healthcare Co., Ltd., rated "high" severity in Argus HQ's classification: Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT 760 with software. On 2026-10-07, Argus HQ recorded an FDA recall for Shanghai United Imaging Healthcare Co., Ltd., rated "high" severity in Argus HQ's classification: Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Positron Emission Tomography and Computed Tomography System, Model: uMI 780. On 2026-10-07, Argus HQ recorded an FDA recall for Shanghai United Imaging Healthcare Co., Ltd., rated "high" severity in Argus HQ's classification: Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT ATLAS with software. On 2026-10-07, Argus HQ recorded an FDA recall for Shanghai United Imaging Healthcare Co., Ltd., rated "high" severity in Argus HQ's classification: Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT 780 with software. On 2026-10-07, Argus HQ recorded an FDA recall for Shanghai United Imaging Healthcare Co., Ltd., rated "high" severity in Argus HQ's classification: Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT 530 with software. On 2026-10-07, Argus HQ recorded an FDA recall for Shanghai United Imaging Healthcare Co., Ltd., rated "high" severity in Argus HQ's classification: Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with…. On 2026-10-07, Argus HQ recorded an FDA recall for Shanghai United Imaging Healthcare Co., Ltd., rated "high" severity in Argus HQ's classification: Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo…. On 2026-10-07, Argus HQ recorded an FDA recall for Shanghai United Imaging Healthcare Co., Ltd., rated "high" severity in Argus HQ's classification: Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama….
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Shanghai United Imaging Healthcare Co., Ltd. has 12 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.
Frequently asked questions
- What is the most recent FDA action against Shanghai United Imaging Healthcare Co., Ltd.?
- The most recent FDA event Argus HQ has on file for Shanghai United Imaging Healthcare Co., Ltd. is dated 2026-10-07, 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.
- Does Argus HQ track new FDA actions for Shanghai United Imaging Healthcare Co., Ltd. automatically?
- Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Shanghai United Imaging Healthcare Co., Ltd. is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for Shanghai United Imaging Healthcare Co., Ltd.?
- 12 total: 0 warning letters, 12 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for Shanghai United Imaging Healthcare Co., Ltd.?
- October 7, 2026. Argus HQ ingests new FDA enforcement records daily.
Every FDA action tied to this company, the week it happens.
Free weekly briefing. Real-time alerts on paid plans.
Related enforcement actions
- Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama… →
- Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo… →
- Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with… →
- Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT 530 with software →
- Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT 780 with software →
- Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT ATLAS with software →
- Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Positron Emission Tomography and Computed Tomography System, Model: uMI 780 →
- Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT 760 with software →
- Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo… →
- Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT 550 with software →
Compare with
- Shanghai United Imaging Healthcare Co., Ltd. vs Philips North America
- Shanghai United Imaging Healthcare Co., Ltd. vs Medline Industries, LP
- Shanghai United Imaging Healthcare Co., Ltd. vs Boston Scientific Corporation
- Shanghai United Imaging Healthcare Co., Ltd. vs Baxter Healthcare Corporation
- Shanghai United Imaging Healthcare 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: Oct 7, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Regulatory Record: Shanghai United Imaging Healthcare Co., Ltd.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/shanghai-united-imaging-healthcare-co-ltd
"Regulatory Record: Shanghai United Imaging Healthcare Co., Ltd.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/shanghai-united-imaging-healthcare-co-ltd.
Argus HQ Research. "Regulatory Record: Shanghai United Imaging Healthcare Co., Ltd.." Digital Empire Holdings LLC. Accessed October 13, 2026. https://argushq.ai/company/shanghai-united-imaging-healthcare-co-ltd.
@misc{argushq_argushq_ai_company_shanghai_united_imaging_healthcare_co_ltd_2026,
title = {Regulatory Record: Shanghai United Imaging Healthcare Co., Ltd.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/company/shanghai-united-imaging-healthcare-co-ltd},
note = {Accessed: October 13, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗

