FDAClass IIApril 15, 2015

INFX-8000V Interventional Angiography System. CAT-880B recall

INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic…

Why was INFX-8000V Interventional Angiography System. CAT-880B 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial No. U7E1462009, ACA1472001, UEB1352004, UFD1442017, AAA1492001, ACA1492002, ULD1412014, AHA1482001, UPB1372006, ULD1392013, U6A1472001, ULD1452016, UPB1352005, ULD1452015, UDE1352017, A4B1472002, U4A14X2001, UPB1342004, 99B1342133, 99B1342134, UFD1452018, UFD13X2015, UFD13X2016, UFD1362014, UUC1452012, A6A1492002, UUC13Z2011, AAA14X2002, A4A13Z2001.

Product
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic…
Recalling firm
Toshiba American Medical Systems Inc
Quantity
28 units
Distribution
Nationwide Distribution
Recall date
April 15, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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