Z-1394-2015Class II

INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular...

Name: Z-1394-2015 INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular...
Creator: Toshiba American Medical Systems Inc
Published: 2015-03-11
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2015-03-11 / Terminated / root cause: design

FDA source

Toshiba American Medical Systems Inc began a recall of INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For... on 2015-03-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1394-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-11
Posted: 2015-04-06
Terminated: 2015-09-18
Recalling firm: Canon Medical Systems USA, Inc.
Product: 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 code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: design
FDA root cause: Device Design
Action: Toshiba sent a Urgent Medical Device Correction letter dated March 11, 2015, to all customers who purchased the CAT-880B catherization table for the Tosiba Infinix X-Ray Interventional System. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return the attached form and fax it to (877) 349-3054 or email to [email protected]. Customers with questions were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968. For questions regarding this recall call 714-730-5000.
Quantity in commerce: 28 units
Distribution: Nationwide Distribution
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1394-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1394-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-06

Product code OWB

K143225Class IIINFX-8000V with Wireless FootswitchToshibamedical Systems Corporation / cleared 2015-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)