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Toshiba American Medical Systems Inc recalls INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Recalled February 17, 2016 · FDA recall Z-0752-2016 · Toshiba American Medical Systems
Hazard
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". · FDA Class II
Units
4
Sold at
US Nationwide Distribution to OH and NY
Description
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".
Product
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Manufacturer(s)
Toshiba American Medical Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →