Recall Z-0907-2014 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
| Date | Feb 3, 2014 (initiated Nov 15, 2013) |
| Status | Terminated |
| Reason | During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B. |
| Root cause | Software design |
| Action | A recall notification letter, dated November 15, 2013, was sent to Users. |
| Quantity | 147 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |