Lower riskMedical device recall · FDA · Published May 8, 2020
uCT 530 CT Scanner Recall: False Marking and Radiation Risks
Shanghai United Imaging Healthcare recalls uCT 530 CT scanners with software version R001.11.0.729741-Re-1100 due to potential false channel marking and radiation exposure risks from 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.
Take action
Contact the company
📍Recalling firmShanghai United Imaging Healthcare Co., Ltd.No. 2258 Chengbei Rd, Jiading Ind. · Shanghai, China
“uCT 530 CT Scanner Recall: False Marking and Radiation Risks.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65201-uct-530-ct-scanner-recall-false-marking-and-radiation-risks. Based on FDA recall #Z-2472-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2472-2020%22&limit=1).
Shanghai United Imaging Healthcare Co., Ltd. voluntarily recalled four uCT 530 Computed Tomography X-Ray Systems on May 8, 2020, according to the FDA. The devices may produce false markings or scanning interruptions, potentially requiring patient rescans and additional radiation exposure.
How to tell if you have it
uCT 530 Computed Tomography X-Ray System
Software version R001.11.0.729741-Re-1100
Serial numbers: 300162, 300163, 300174, 300176
GTINs: 6971576831012
UPC: 06971576831012
The hazard
The recall cites 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 Philips IQon Spectral CT Software 4.7.7.x Recall (Aug. 7, 2026), Philips Brilliance CT 64 Medical Scanner Recall (Aug. 7, 2026), and Philips Ingenuity CT Scanners: Unintended Radiation Risk (Aug. 7, 2026).
How to tell if you have this one
Check for serial numbers 300162, 300163, 300174, or 300176 with software version R001.11.0.729741-Re-1100.
Brand
Shanghai United Imaging Healthcare
Product
uCT 530 Computed Tomography X-Ray System
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on the device; affected units have version R001.11.0.729741-Re-1100.
Where it went and when
Where it was distributed
Distributed in Texas.
Listed by the agency
Not listed
FDA distribution: “Distributed to Texas.” 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-2472-2020 (May 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2472-2020 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.