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.
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.
The CT scanner may falsely mark a bad channel, causing ring artifacts in images and potentially requiring rescan. This could lead to additional radiation exposure and contrast media use for the patient.
Patients using the uCT 550 CT scanners with serial numbers 353020, 353021, or 353023 (software version R001.11.0.729741-Re-1100) are most at risk of unnecessary radiation exposure during scans.
Check for serial numbers 353020, 353021, or 353023 with software version R001.11.0.729741-Re-1100 on the uCT 550 CT scanner.
Identify the serial number on your uCT 550 scanner to see if it matches 353020, 353021, or 353023.
The uCT 550 CT scanner with serial numbers 353020, 353021, and 353023 (software version R001.11.0.729741-Re-1100).
The scanner may falsely mark a bad channel, causing ring artifacts and potentially requiring rescan, which could lead to extra radiation exposure and contrast media use.
No action is needed if your scanner's serial number is not listed or software version is different.
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-2641-2020 — Shanghai United Imaging Healthcare Shanghai United Imaging Healthcare Hello, I own a Shanghai United Imaging Healthcare that is covered by recall Z-2641-2020 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.
