Has Shanghai United Imaging Healthcare Co., Ltd. had other FDA enforcement actions?

Yes. Argus HQ has recorded 12 total FDA actions tied to Shanghai United Imaging Healthcare Co., Ltd.: 0 warning letters, 12 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 2026-10-07; Argus observed and indexed it on 2026-10-13.

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

Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT 550 with software

Name: FDA Recall Record — Shanghai United Imaging Healthcare Co., Ltd.
Creator: Argus HQ
Published: 2026-10-07
License: https://argushq.ai/methodology

Event date: 2026-10-07 00:00:00Z
Observed: 2026-10-13 04:20:29Z
Source ID: Z-3278-2026
Payload hash: 367b13d1659373c7e2515ace…

Summary

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the… Status: Ongoing.

Entities

Shanghai United Imaging Healthcare Co., Ltd.

View source record ↗

Frequently asked questions

Has Shanghai United Imaging Healthcare Co., Ltd. had other FDA enforcement actions?: Yes. Argus HQ has recorded 12 total FDA actions tied to Shanghai United Imaging Healthcare Co., Ltd.: 0 warning letters, 12 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 2026-10-07; Argus observed and indexed it on 2026-10-13.
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 (2026). Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT 550 with software. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-shanghai-united-imaging-healthcare-co-ltd-z-3278-2026

MLA

"Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT 550 with software." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-shanghai-united-imaging-healthcare-co-ltd-z-3278-2026.

Chicago

Argus HQ Research. "Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT 550 with software." Digital Empire Holdings LLC. Accessed October 13, 2026. https://argushq.ai/events/fda-recall-shanghai-united-imaging-healthcare-co-ltd-z-3278-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_shanghai_united_imaging_healthcare_co_ltd_z_3278_2026_2026,
  title = {Shanghai United Imaging Healthcare Co., Ltd. — Class II recall: Computed Tomography X-ray System, Model: uCT 550 with software},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-shanghai-united-imaging-healthcare-co-ltd-z-3278-2026},
  note = {Accessed: October 13, 2026}
}

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