Shanghai United Imaging Healthcare—uCT 530 Computed Tomography X-Ray Systems: False Markings and Scanning Errors May Occur

July 8, 2020 | Risk Management News

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ECRI's complete weekly summary of medical device hazard and recall information is available in ECRI's Health Device Alerts. For more information contact us at clientservices@ecri.org.

FDA's Center for Devices and Radiological Health (CDRH) states that software errors in the above systems may cause false markings of a bad channel resulting in ring artifacts and intermittent scout scanning interruption caused by angle signal drift. FDA's CDRH also states that these problems may necessitate patient rescanning, resulting in an additional radiation dose and additional contrast medium. FDA's CDRH further states that the manufacturer initiated a correction by e-mail on May 22, 2020. The manufacturer has not confirmed the...

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