FDA-Device2016-02-17Class II
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Toshiba American Medical Systems Inc
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".
Sold states
US Nationwide Distribution to OH and NY
Affected count
4
Manufactured in
PO Box 2068, 2441 Michelle Dr, Tustin, CA, United States
Products
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0752-2016Don't want to check this manually?
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