Shanghai United Imaging Healthcare recalls uMI 550 CT scanners with specific software versions due to potential image display issues during bolus tracking. Affected units may require manual scanning, risking patient rescan. Contact for remedy details.
In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan.
Shanghai United Imaging Healthcare is recalling uMI 550 CT scanners with software version R001.3.0.0.750505. This software issue may cause the CT Hounsfield unit curve to not display in real time during bolus tracking, potentially requiring manual scanning and patient rescan.
The software issue prevents real-time display of the Hounsfield unit curve during bolus tracking protocols. This may force healthcare providers to manually restart scanning protocols, potentially leading to patient rescan.
Healthcare professionals using the uMI 550 CT scanners with the specific software version. Patients may be at risk of additional scans if the issue occurs during procedures.
Check for software version R001.3.0.0.750505 on the uMI 550 CT scanner. Affected units have serial numbers 200017, 200023, or 200024.
Verify the software version on your uMI 550 scanner; affected units have version R001.3.0.0.750505.
The affected software version is R001.3.0.0.750505.
The subsequent clinical scanning protocols may need to be started manually, potentially resulting in patient rescan.
Serial numbers 200017, 200023, and 200024 are affected.
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-2819-2020 — Shanghai United Imaging Healthcare Shanghai United Imaging Healthcare Hello, I own a Shanghai United Imaging Healthcare that is covered by recall Z-2819-2020 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.
