Sienet Cosmos V15C, picture archiving and communications system. Model number 10018969
FDA device recall Z-0069-2007 · posted 2006-10-25 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Potential loss of images. Images may not successfully be sent to the RAID system.
- Action taken
- The recalling firm has issued a software patch to resolve the issue via Update Instructions HS110/06/S. The Update Instructions direct a Siemens Service Representative to visit the affected sites, install the software patch to resolve the issue, and hand deliver a Customer Advisory Notice, dated September 20th, 2006, to the customer to notify them of the issue.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 5 units
- Distribution
- The product was shipped to hospitals in CA, MD, MO, and PA
- Date initiated
- 2006-10-03
- Date posted
- 2006-10-25
- Date terminated
- 2008-04-23
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIENET COSMOS (VERSION V15A) (K042832) | Siemens AG Medical Solutions | 2004-10-28 |