Recall Z-0107-2016 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
| Date | Oct 6, 2015 (initiated Aug 18, 2015) |
| Status | Terminated |
| Reason | Software and firmware bugs |
| Root cause | Software design |
| Action | Customers will be notified via the system interface and e-mail or U.S. postal mailing via a Customer Advisory Notice. If necessary the advisory letter may be hand delivered. The letter informed customers that the safety related issues identified were resolved by SW-Version VA50A_SP2. The update will be remotely pushed to affected systems. The letter also advised customers to notify anyone in their organization that should be aware of the information. In the event that the device had been sold, the notice should be forwarded to the new owner, and the firm should be informed of the new owne |
| Quantity | 21 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133589 | SOMATOM FORCE Siemens Medical Solutions USA, Inc., Apr 17, 2014 |