Recall Z-1560-2016 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications
| Date | Apr 12, 2016 |
| Status | Terminated |
| Reason | Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry. |
| Root cause | Device Design |
| Action | An Urgent Medical Device Correction letter dated 4/12/16 was sent to a customer to bring to the customer's attention with a potential problem with the Aquilion Lightning CT System iStation cover. The letter informs the customer that the iStation cover may come off due to deficient dimensional geomtry. The letter informs the customer of the problem identified and corrective action to be taken. The customer is instructed to complete and return the attached form and fax it to (877) 349-3054. If the customer has any questions regarding the recall letter, then the customer is instructed to cont |
| Quantity | 1 unit |
| Distribution | US in the state Nevada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151833 | Aquilion Lightning (TSX-035A/2, V7.0) Toshibamedical Systems Corporation, Oct 9, 2015 |