Recall Z-1394-2015 ยท OWB Interventional Fluoroscopic X-Ray System
Toshiba American Medical Systems Inc
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.
| Date | Apr 6, 2015 (initiated Mar 11, 2015) |
| Status | Terminated |
| Reason | 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 | 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 | 28 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143225 | INFX-8000V with Wireless Footswitch Toshibamedical Systems Corporation, Jan 9, 2015 |