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.
Shanghai United Imaging Healthcare is recalling uCT 530 CT scanners with specific software versions. These units may cause false channel markings leading to rescans, which could increase radiation exposure and contrast medium use.
The CT scanner's software may misidentify faulty channels, causing the need for rescans. This can increase radiation exposure and require additional contrast media for patients.
Healthcare facilities using uCT 530 CT scanners with software version R001.11.0.729741-Re-1100 are affected. Patients undergoing scans with these units may face additional radiation exposure.
Check for serial numbers 300162, 300163, 300174, or 300176 with software version R001.11.0.729741-Re-1100.
Verify the software version on the device; affected units have version R001.11.0.729741-Re-1100.
The CT scanner may misidentify faulty channels, requiring rescans that increase radiation exposure and contrast media use.
Check for serial numbers 300162, 300163, 300174, or 300176 with software version R001.11.0.729741-Re-1100.
The recall does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Shanghai United Imaging Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2472-2020 — Shanghai United Imaging Healthcare Shanghai United Imaging Healthcare Hello, I own a Shanghai United Imaging Healthcare that is covered by recall Z-2472-2020 from Shanghai United Imaging Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
