FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A. Picture Archiving and communications system
- Recall number
- Z-1266-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A. Picture Archiving and communications system
- Status
- Terminated
- Initiated
- 2009-02-09
- Posted
- 2009-04-28
- Terminated
- 2009-09-23
- Reason
- An issue concerning archived image data that is sporadically saved with corrupted data may occur. This issue may occur when syngo Imaging is configured to archive image data on a network file system (NFS) connected via a connected archive (Mount Point Solution).
- Root cause
- Software design
- Action
- A Customer Safety Advisory Notice, dated 02/09/2009 was sent to affected customers via Update Instruction IM013/09S. The letter informs customers of when the malfunction occurs and the potential issue, provides instructions to avoid its occurrence, and how the issue will be resolved. Customers are to ensure that the Safety Advisory is placed in the system's instructions for use and contact their SIEMENS Uptime Service Senter if they have any questions.
- Quantity
- 20 units
- Distribution
- Nationwide Distribution -- including states of AL, CA, CT, FL, LA, MI, MO, NC, NJ, OH, PA, TN, and WI.
- Lot, serial or model codes
- Serial numbers: 1279, 1210, 1246, 1198, 1105, 1227, 1064, 1058, 1083, 1090, 1189, 1061, 1258, 1119, 1039, 1040, 1074, 1079, 1282 and 1056.
- 510(k) numbers
- not on file
- 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