Toshiba American Medical Systems Inc recalls INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fl…

Recall date

March 11, 2015

Source

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

Recall number

Z-1394-2015

FDA classification

Class II

Brand / firm

Toshiba American Medical Systems Inc

Sold / distributed

Nationwide Distribution

Why it was recalled

The table base rotational brake that holds the table top may not always be engaged when any force or side impact is applied to the table top.

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 Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.