Shanghai United Imaging Healthcare recalls uCT 550 CT scanners with serial numbers 353020-353023 (software R001.11.0.729741-Re-1100) due to potential false channel marking causing extra radiation exposure and rescan needs.
Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.
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Contact the company
📍Recalling firmShanghai United Imaging Healthcare Co., Ltd.No. 2258 Chengbei Rd, Jiading Ind. · Shanghai, China
✎ GovInfoNow plain-language explainer
Shanghai United Imaging Healthcare is recalling specific uCT 550 CT scanners that may cause extra radiation exposure and rescan needs if false channel marking occurs. This could lead to additional radiation doses and contrast media use for affected patients. Read more at govinfonow.com/recall/65097-uct-550-ct-scanner-recall-radiation-dose-risk-from-false.
“uCT 550 CT Scanner Recall: Radiation Dose Risk from False Marking.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65097-uct-550-ct-scanner-recall-radiation-dose-risk-from-false. Based on FDA recall #Z-2641-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2641-2020%22&limit=1).
The FDA announced on May 23, 2020, that Shanghai United Imaging Healthcare Co., Ltd. is recalling Computed Tomography X-ray Systems, Model uCT 550. The devices may cause false markings or scanning interruptions, potentially requiring patient rescans.
The recall addresses two issues: a service function that may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift. If these problems occur, it may be necessary to rescan the patient, resulting in an additional dose of radiation and the possible need for additional contrast medium.
Context
GovInfoNow's records show Shanghai United Imaging Healthcare Co., Ltd. has 14 other recalls on record since July 30, 2019. Other recent recalls of similar products include Positron Emission Tomography and Computed Tomography System Recall (Aug. 11, 2026), uMI PET/CT Scanners Software Issue Recall (March 1, 2023), and uMI 550 PET/CT System Recall (May 30, 2022). Other recent recalls of similar products include Philips IQon Spectral CT Software Recall (Aug. 7, 2026), Philips Brilliance CT 64 Medical Scanner Recall (Aug. 7, 2026), and Philips Ingenuity CT Scanners Recall (Aug. 7, 2026).
How to tell if you have this one
Check for serial numbers 353020, 353021, or 353023 with software version R001.11.0.729741-Re-1100 on the uCT 550 CT scanner.
Brand
Shanghai United Imaging Healthcare
Product
Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Scanner Serial Number
Identify the serial number on your uCT 550 scanner to see if it matches 353020, 353021, or 353023.
Where it went and when
Where it was distributed
Distributed in Texas.
Listed by the agency
Not listed
FDA distribution: “US Distribution to state of: TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2641-2020 (May 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2641-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.