Reported Apr 15, 2015 · Terminated
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with…
Toshiba American Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Toshiba American Medical Systems Inc · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- 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.
- Lot codes and dates
Serial No. U7E1462009ACA1472001UEB1352004UFD1442017AAA1492001ACA1492002ULD1412014AHA1482001UPB1372006ULD1392013U6A1472001ULD1452016UPB1352005ULD1452015UDE1352017A4B1472002U4A14X2001UPB134200499B134213399B1342134UFD1452018UFD13X2015UFD13X2016UFD1362014UUC1452012A6A1492002UUC13Z2011AAA14X2002A4A13Z2001
- Amount recalled
- 28 units
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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