Recall Z-1607-2016 ยท KPS System, Tomography, Computed, Emission
Toshiba American Medical Systems Inc
Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D images) of the whole human body (including the head). The CT images provide morpholo
| Date | May 4, 2016 (initiated Apr 24, 2016) |
| Status | Terminated |
| Reason | Potential degradation of detector performance. |
| Root cause | Device Design |
| Action | Toshiba sent an Urgent Medical Device Correction letter dated April 24, 2016 to all affected customers. The letter informed customers that Toshiba America Medical Systems is bringing attention to a potential problem with the Celestion PET/CT System. The letter informed the customers of a potential degradation of detector performance and informed the customers of the problems and the corrective actions to be taken. Customers were instructed to complete and return the attached form and fax it to (877) 349-3054 or be sent via email to regulatoryaffairs@toshiba.com. Customers with questions |
| Quantity | 3 units |
| Distribution | US Distribution to WI and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140651 | CELESTEION, PCA-9000A/2 Toshibamedical Systems Corporation, Jun 11, 2014 |