Recall Z-0972-2014 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
| Date | Mar 6, 2014 (initiated Dec 11, 2013) |
| Status | Terminated |
| Reason | Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed. |
| Root cause | Other |
| Action | Toshiba America Medical Systems, Inc. initiated this recall by sending "Urgent Medical Device Correction," letter dated December 11, 2013, informed customers of the recall by providing, the device name, serial number, problem statement, corrective action statement, and contact information. A customer reply form accompanied the recall notification letter. Strategy: The majority of the letters are sent via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. After two weeks contact will be made with each non responding location and a copy |
| Quantity | 8 units |
| Distribution | US Distribution including the states of: MD, WV, OH, CA, MN, IN, NY and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132222 | AQUILION ONE VISION, V6.0 Toshibamedical Systems Corporation, Nov 7, 2013 |