FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens syngo.plaza radiological image processing system.
- Recall number
- Z-0048-2013
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens syngo.plaza radiological image processing system.
- Status
- Terminated
- Initiated
- 2012-06-06
- Posted
- 2012-10-11
- Terminated
- 2013-04-13
- Reason
- Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.
- Root cause
- Software design
- Action
- The firm initiated this correction on June 6, 2012 by issuing update instructions SY129/12/S to consignees. A script will be distributed to all potential affected customer systems which will prevent data loss by setting the delete protection on all affected studies.
- Quantity
- 11
- Distribution
- Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA.
- Lot, serial or model codes
- Model number 10592457, serial numbers 100263, 100401, 100177, 100138, 100174, 100406, 100249, 100201, 100198, 100181, 100146.
- 510(k) numbers
- K093612
- 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