Shanghai United Imaging Healthcare recalls uCT 760 CT scanners with specific serial numbers and software versions due to potential image artifacts and radiation dose increases from rescanning.
Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media.
Shanghai United Imaging Healthcare is recalling uCT 760 CT scanners that may cause image artifacts and require rescanning, increasing radiation exposure and contrast media use. This could lead to unnecessary radiation doses for patients.
The CT scanner may produce image artifacts and occasionally interrupt scout scans due to angle signal drift. This could require rescanning the patient, increasing radiation exposure and possibly needing additional contrast media.
Patients using the uCT 760 CT scanners with specific serial numbers and software versions may face increased radiation exposure if rescanning is needed. Healthcare facilities using these models are most at risk.
Check for serial numbers 600229, 600230, 600232, 600271, or 600282 with software versions R001.11.0.729741-Re-1100 or R001.11.0.785930-Re-1150.
Identify if your uCT 760 scanner has serial numbers 600229, 600230, 600232, 600271, or 600282 with the specified software versions.
The uCT 760 CT scanner may produce image artifacts and occasionally interrupt scout scans due to angle signal drift, potentially requiring rescanning and increasing radiation exposure.
Check your serial number and software version against the listed numbers to see if you are affected. If affected, contact the manufacturer for further instructions.
The recall addresses potential increased radiation exposure and contrast media use, but does not mention serious injury risks. The hazard level is low risk.
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-2522-2020 — Shanghai United Imaging Healthcare Shanghai United Imaging Healthcare Hello, I own a Shanghai United Imaging Healthcare that is covered by recall Z-2522-2020 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.
