Recall Z-0622-2017 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
| Date | Nov 18, 2016 (initiated Oct 25, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 291 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141741 | AQUILION PRIME, V6.00 Toshibamedical Systems Corporation, Nov 26, 2014 |