Shanghai United Imaging Healthcare recalls uCT 550 CT scanners with serial numbers 353020, 353021, 353023, 353045, 353049 due to potential incorrect radiation exposure during multi-phase scans. Affected units may require correction to prevent unnecessary radiation exposure.
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Shanghai United Imaging Healthcare is recalling specific uCT 550 CT scanners that could cause unnecessary radiation exposure during multi-phase scans. This affects healthcare providers using these machines for medical imaging. The issue requires correction to prevent potential overexposure.
The CT scanner's digital display panel may show an incorrect scan delay timer during multi-phase contrast scans. This could lead to operators receiving unnecessary radiation exposure during medical imaging procedures.
Healthcare facilities using the uCT 550 CT scanners with serial numbers 353020, 353021, 353023, 353045, or 353049 are most at risk. Medical staff performing scans with these units may receive unnecessary radiation exposure.
Check for the serial numbers 353020, 353021, 353023, 353045, or 353049 on the uCT 550 CT scanner. The product is a CT scanner used for producing cross-sectional body images.
Identify if your scanner has serial numbers 353020, 353021, 353023, 353045, or 353049.
The CT scanner's digital display panel may show an incorrect scan delay timer during multi-phase contrast scans, potentially leading to unnecessary radiation exposure for operators.
Check if your scanner has the listed serial numbers. If it does, contact Shanghai United Imaging Healthcare for further instructions.
The recall addresses potential unnecessary radiation exposure, but the official notice does not specify a risk of serious injury.
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-0446-2021 — Shanghai United Imaging Healthcare Shanghai United Imaging Healthcare Hello, I own a Shanghai United Imaging Healthcare that is covered by recall Z-0446-2021 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.