Shanghai United Imaging Healthcare recalls uMI PET/CT scanners with software issue that may cause PET image reconstruction failure during scans. Affected models include uMI 550 with specific serial numbers and part numbers listed.
Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.
Shanghai United Imaging Healthcare is recalling certain uMI PET/CT scanners due to a software issue that can cause PET image reconstruction to fail during patient scans. This may result in inaccurate or incomplete imaging results, which could affect diagnostic accuracy.
The software issue causes scatter correction to occasionally fail during patient scanning, which may lead to incomplete or inaccurate PET image reconstruction. This could result in incorrect diagnostic conclusions if the images are used for medical decisions.
Medical facilities using the affected uMI 550 PET/CT scanners with specific serial numbers and part numbers listed in the recall notice are most at risk. Patients undergoing scans on these devices may receive inaccurate imaging results.
Check if your scanner has model number 88000657 or 88000057 with serial numbers starting with 230003 or 200017 as listed in the recall notice. The affected units were sold with specific part numbers and serial codes.
Verify your scanner's model number and serial number against the list of affected units provided in the recall notice.
The recall states that a software issue may cause scatter correction to fail during patient scanning, potentially leading to incomplete PET image reconstruction.
The recall does not specify a stop-use instruction; affected units should be checked against the provided serial numbers and part numbers.
Check your scanner's model number and serial number against the list of affected units (model 88000657 or 88000057 with specific serial numbers starting with 230003 or 200017).
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-1353-2023 — Shanghai United Imaging Healthcare Shanghai United Imaging Healthcare Hello, I own a Shanghai United Imaging Healthcare that is covered by recall Z-1353-2023 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.
