Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation al
FDA device recall Z-0622-2017 · posted 2016-11-18 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system operation.
- Action taken
- Toshiba American Medical Systems, Inc. sent an Urgent Medical Device Correction letter dated October 25, 2016, to all affected customers who received the Aquilion CT system to inform them that Toshiba America Medical System has received reports that the cooling oil in the x-ray tube heat exchanger may leak during system operation. The letter informs the customers of the description found and corrective action. Customers were instructed to complete the attached customer reply form and fax it to (877) 349-3054 or send it to raffairs@tams.com. Customers with questions are 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
- JAK
- Quantity affected
- 291 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2016-10-25
- Date posted
- 2016-11-18
- Date terminated
- 2017-08-19
- Location
- Tustin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AQUILION PRIME, V6.00 (K141741) | Toshibamedical Systems Corporation | 2014-11-26 |