Toshiba American Medical Systems Inc recalls INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems

Recall date

August 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0752-2016

FDA classification

Class II

Brand / firm

Toshiba American Medical Systems Inc

Sold / distributed

US Nationwide Distribution to OH and NY

Why it was recalled

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".

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems