Company: Toshiba American Medical Systems Inc.
Date of Enforcement Report 2/17/2016
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Recall Number Z-0752-2016
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”.
Toshiba American Medical Systems Inc., Tustin, CA on 8/4/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
US Nationwide Distribution to OH and NY