Recall Z-2626-2016 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
| Date | Aug 23, 2016 (initiated Jul 13, 2016) |
| Status | Terminated |
| Reason | Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector. |
| Root cause | Software in the Use Environment |
| Action | Siemens mailed to customers an Important Customer Safety Notice to inform about a possible malfunction when using the affected systems and what actions to take to eliminate the problem. Also, Siemens informed their customers that they were currently developing a new firmware to eliminate the internal communication error, which should be released in August 2016. Customers were asked to contact their service organization at 800-888-7436, if they had any questions. |
| Quantity | 4 systems |
| Distribution | Distributed to: MI, NY, CA, KY, ND, NE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143401 | SOMATOM Definition Edge Siemens Medical Solutions USA, Inc., Apr 6, 2015 |