Shanghai United Imaging Healthcare recalls uMI 550 PET/CT scanners with specific software version R001.3.0.0.750505 due to potential PET acquisition data issues that could lead to rescans and additional patient radiation doses. Affected units have serial numbers 200017 and 200023.
Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.
Shanghai United Imaging Healthcare is recalling uMI 550 PET/CT scanners with software version R001.3.0.0.750505. This software version may cause reconstruction problems during scans, potentially requiring rescans and increasing patient radiation exposure.
The software version R001.3.0.0.750505 may cause errors in PET scan data reconstruction. This could lead to rescans of patients, which would increase their radiation exposure without improving diagnostic accuracy.
Healthcare facilities using the uMI 550 scanner with software version R001.3.0.0.750505 are affected. Patients undergoing scans on these systems may face additional radiation doses if rescans are needed.
Check for the model uMI 550 with software version R001.3.0.0.750505. Affected units have serial numbers 200017 and 200023. The product is intended for use by healthcare professionals in medical settings.
Verify the software version on your uMI 550 scanner; affected units have version R001.3.0.0.750505.
The software version R001.3.0.0.750505 may cause reconstruction problems during PET/CT scans, potentially requiring rescans and increasing patient radiation exposure.
Affected units have serial numbers 200017 and 200023 and software version R001.3.0.0.750505.
No action is required for the software issue; healthcare professionals should check the software version and monitor for potential scan issues.
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-1708-2020 — Shanghai United Imaging Healthcare Shanghai United Imaging Healthcare Hello, I own a Shanghai United Imaging Healthcare that is covered by recall Z-1708-2020 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.
