INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems — recall Z-0752-2016
U.S. FDA — Device Enforcement · United States · 2015-08-14 · Class II
As described by U.S. FDA — Device Enforcement: INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide Distribution to OH and NY
Reported risk: When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".
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