SOMATOM CT System Emotion 16. Computed tomography x-ray system.
FDA device recall Z-0793-06 · posted 2006-04-26 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.
- Action taken
- The recalling firm has issued a software patch to the affected customers per Update Instructions CT086/05/S and CT087/05/S. By letter 3/9/2006. In addition, a Siemens Service Engineer will visit affected sites to install this software patch which will resolve this issue.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 5 units
- Distribution
- Nationwide. The product was shipped to AK, AZ, CA, DE, FL, GA, IL, IN, KY, LA, MD, ME, MI, MT, NC, NY, OH, OK, PA, PR, TX, UT, VA, WA and WI.
- Date initiated
- 2006-03-09
- Date posted
- 2006-04-26
- Date terminated
- 2006-07-19
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM EMOTION 16 (K050297) | Siemens Medical Solution, Inc. USA | 2005-03-01 |