FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Sienet Cosmos V15C, picture archiving and communications system. Model number 10018969
- Recall number
- Z-0069-2007
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Sienet Cosmos V15C, picture archiving and communications system. Model number 10018969
- Status
- Terminated
- Initiated
- 2006-10-03
- Posted
- 2006-10-25
- Terminated
- 2008-04-23
- Reason
- Potential loss of images. Images may not successfully be sent to the RAID system.
- Root cause
- Other
- Action
- 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.
- Quantity
- 5 units
- Distribution
- The product was shipped to hospitals in CA, MD, MO, and PA
- Lot, serial or model codes
- Model number 10018969. Serial numbers 1001, 1010, 1011, 1028, 1029
- 510(k) numbers
- ["K042832"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28