Recall Z-2453-2008 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Emotion 16. Computed tomography X-ray system
| Date | Sep 21, 2008 (initiated Aug 5, 2008) |
| Status | Terminated |
| Reason | Potential electrical shock hazard. The LCB power Switch (S1) could break causing the protective plastic cap to come off exposing the energized electrical contacts within the switch. The LCB S1 does have an inline fuse which is designed to open in the event of a short circuit condition between the internal switch contacts. |
| Root cause | Nonconforming Material/Component |
| Action | The firm issued and Safety Update in July 2008 informing users that the firm will have representatives visit each account to replace the cap per Update Instructions CT032/08/S. |
| Quantity | 53 units |
| Distribution | Nationwide including states of AK, AL, CO, FL, GA, IA, ID, IL, IN, LA, MD, MN, MS, NC, NE, NY, OH, OK, OR, RI, SD, TX, UT, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050297 | SOMATOM EMOTION 16 Siemens Medical Solution, Inc. USA, Mar 1, 2005 |