Shanghai United Imaging Healthcare recalls uMI 550 PET/CT scanners with serial numbers 200017, 200023, 200024, and 200036 due to potential false channel markings and scanning interruptions. Affected healthcare facilities should contact the manufacturer for details.
1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions (N/A for Serial No. 200036)
Shanghai United Imaging Healthcare is recalling specific uMI 550 PET/CT scanners that may show false scan results or interrupt scanning. This could lead to repeat scans and minor skin abrasions if the scanner's metal components cause sharp edges.
The scanners may produce false channel markings causing ring artifacts in scans. External interference can cause temporary scanning interruptions. Metal edges in the scanner's mylar strip might create sharp edges that could cause minor skin abrasions during repeated scans.
Healthcare facilities using the uMI 550 PET/CT scanners with serial numbers 200017, 200023, 200024, and 200036 are most at risk. Patients undergoing scans with these models may experience repeat scans or minor skin irritation.
Check for serial numbers 200017, 200023, 200024, and 200036 on the uMI 550 PET/CT scanners. These models are intended for use by qualified healthcare professionals.
Identify if your scanner has serial numbers 200017, 200023, 200024, or 200036.
The uMI 550 PET/CT scanners may show false channel markings causing ring artifacts in scans, have temporary scanning interruptions due to external interference, and create sharp edges that could cause minor skin abrasions during repeated scans.
The recall does not specify a remedy, so contact Shanghai United Imaging Healthcare directly for further instructions.
Patients using the recalled scanners may experience repeat scans or minor skin abrasions if the scanner's metal components create sharp edges.
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-2800-2020 — Shanghai United Imaging Healthcare Shanghai United Imaging Healthcare Hello, I own a Shanghai United Imaging Healthcare that is covered by recall Z-2800-2020 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.
