SOMATOM Emotion 6. Computed tomography X-ray system
FDA device recall Z-2452-2008 · posted 2008-09-21 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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.
- Date initiated
- 2008-08-05
- Date posted
- 2008-09-21
- Date terminated
- 2008-11-07
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM EMOTION 6 CT SYSTEMS (K023687) | Siemens Medical Systems, Inc. | 2002-11-22 |