Recall Z-0005-2016 ยท KPS System, Tomography, Computed, Emission
Toshiba American Medical Systems Inc
Celesteion PCA-9000A/2 PET/CT System
| Date | Oct 7, 2015 (initiated May 8, 2015) |
| Status | Terminated |
| Reason | It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem. |
| Root cause | Device Design |
| Action | Planned Action by Toshiba Medical America Systems to address the defect: a. A notification will be sent to the customer with affected system in compliance with 21 CFR1 003.21 upon approval by the Secretary. b. To correct this issue revised software will be installed on the system to prevent this occurrence from happening. The consignee will be contacted by their Toshiba service representative for an appointment when the revised software becomes available. c. The customer will be advised to do the following until the corrective measures have been taken, i.e., revised software installed on thei |
| Quantity | 1 |
| Distribution | US Distribution to the state of Nevada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140651 | CELESTEION, PCA-9000A/2 Toshibamedical Systems Corporation, Jun 11, 2014 |