Recall Z-1303-2016 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
| Date | Feb 15, 2016 |
| Status | Terminated |
| Reason | Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with the use of the cardio licenses "Cardio Pro" and "Cardio Retro". |
| Root cause | Device Design |
| Action | A Safety Advisory Notice was sent to customers informing them of a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems. Siemens informed them that they will deliver an Update Instruction for their Service Engineers to modify the installed Firmware. This will correct the rare synchronization errors of Scanner Firmware and Scanner Software to start the application of the x-ray in compliance with the optimum triggering point for best image quality. |
| Quantity | 124 units |
| Distribution | US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013522 | SOMATOM P30 CT SYSTEMS Siemens Medical Systems, Inc., Nov 7, 2001 |