Toshiba American Medical Systems Inc: Medical Device Recall in 2015 - (Recall #: Z-1394-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 11, 2015

Date Posted: April 15, 2015

Recall Number: Z-1394-2015

Event ID: 70748

Reason for Recall:

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.

Status: Terminated

Product Quantity: 28 units

Code Information:

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.

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated