Recall Z-0604-2017 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are 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 | Nov 17, 2016 (initiated Oct 19, 2016) |
| Status | Terminated |
| Reason | A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens' sent a Customer Safety Advisory Notice letter dated October 19, 2016 to affected customers. The letter identified the affected product, problem, potential risks, how to avoid the potential risk related to this issue and actions to be taken. |
| Quantity | 762 systems distrtibuted in U.S. |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143400 | SOMATOM Definition AS/AS+ Siemens Medical Solutions USA, Inc., Apr 8, 2015 |