Sienet Cosmos. Radiological Image Processing. Model number 10018971
FDA device recall Z-0092-06 · posted 2005-10-28 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- reference lines appear above actual position
- Action taken
- The company has issued a Customer Safety Advisory dated 9/22/05 via certified mail to the affected customers per Update Instructions CN038/05/S. The letter informs customers of the issue and also provides customer with instruction to avoid its occurrence.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 64 units
- Distribution
- The product was shipped to medical facilities in CA, CO, FL, IA, KS, LA, MD, MI, MO, NC, and PA.
- Date initiated
- 2005-09-22
- Date posted
- 2005-10-28
- Date terminated
- 2006-08-23
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIENET COSMOS (VERSION V15A) (K042832) | Siemens AG Medical Solutions | 2004-10-28 |