Recall Z-0016-2016 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-301C
| Date | Oct 9, 2015 (initiated May 8, 2015) |
| Status | Terminated |
| Reason | If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Toshiba America Medical Planned Action to bring defect into Compliance: a. A notification will be sent to all consignees with affected systems in compliance with 21 CFR1 003.21 upon approval by the Secretary. b. To correct this issue revised software will be installed on each system to prevent this occurrence from happening. Each consignee will be contacted by their Toshiba service representative for an appointment when the revised software becomes available. c. Each consignee will be advised to do the following until the corrective measures have been taken, i.e., revised software installed |
| Quantity | 459 |
| Distribution | US Distribution including Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142465 | Aquilion ONE Vision, v7.0 Toshibamedical Systems Corporation, Mar 10, 2015 |