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U.S. Department of Health and Human Services

Class 2 Device Recall CAT880B catheterization table for the Toshiba Infinix Xray Interventional System (INFX8000V/U7)

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  Class 2 Device Recall CAT880B catheterization table for the Toshiba Infinix Xray Interventional System (INFX8000V/U7) see related information
Date Initiated by Firm March 11, 2015
Date Posted April 06, 2015
Recall Status1 Terminated 3 on September 18, 2015
Recall Number Z-1394-2015
Recall Event ID 70748
510(K)Number K143225  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
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.
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.
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer 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.
FDA Determined
Cause 2		 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 raffairs@tams.com. 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = TOSHIBA MEDICAL SYSTEMS CORPORATION
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