FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Sienet Sky, picture archiving and communications system. Model number 8463163
- Recall number
- Z-0071-2007
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Sienet Sky, picture archiving and communications system. Model number 8463163
- Status
- Terminated
- Initiated
- 2006-09-05
- Posted
- 2006-10-25
- Terminated
- 2008-09-17
- Reason
- Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.
- Root cause
- Other
- Action
- The recalling firm has issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions HS096/06/S and HS097/06/S. The letter, dated September 5, 2006, informs customers of this issue and provides recommendations to avoid its occurrence.
- Quantity
- 1818 units total, for all three products
- Distribution
- The product was shipped to medical facilities nationwide.
- Lot, serial or model codes
- Model number 8463163, all versions.
- 510(k) numbers
- ["K935694"]
- 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