FDA-Device2015-04-15Class II
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.
Toshiba American Medical Systems Inc
Hazard
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.
Sold states
Nationwide Distribution
Affected count
28 units
Manufactured in
2441 Michelle Dr, P.O. Box 2068, Tustin, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1394-2015Don't want to check this manually?
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