Recall Z-1934-2015 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
| Date | Jun 27, 2015 (initiated Jun 4, 2015) |
| Status | Terminated |
| Reason | A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site. |
| Root cause | Device Design |
| Action | A safety advisory notice, dated June 4, 2015, was sent to direct accounts explaining the problem and potential risk to patients and operators. Siemens engineers will begin replacing the bolts in May 2015. |
| Quantity | 40 total |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133424 | SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 Siemens Medical Solutions USA, Inc., Jan 17, 2014 |