Recall Z-0373-2017 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Definition AS system, x-ray, tomography, computed
| Date | Nov 8, 2016 (initiated Oct 19, 2016) |
| Status | Terminated |
| Reason | Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens mailed a Customer Safety Advisory Notice to affected customers on October 19, 2016, to inform them about the hardware issue. The notice provided guidance on risk prevention and actions they are taking to develop a solution to correct the issue. For further questions, please call (610) 448-6471. |
| Quantity | 57 systems distributed in USA |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143409 | SOMATOM Definition AS Open (VA48) Siemens Medical Solutions USA, Inc., Mar 26, 2015 |