INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with flu
FDA device recall Z-1394-2015 · posted 2015-04-06 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 28 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-03-11
- Date posted
- 2015-04-06
- Date terminated
- 2015-09-18
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFX-8000V with Wireless Footswitch (K143225) | Toshibamedical Systems Corporation | 2015-01-09 |