FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: syngo.plaza Image processing system
- Recall number
- Z-0522-2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- syngo.plaza Image processing system
- Status
- Terminated
- Initiated
- 2011-09-21
- Posted
- 2012-01-11
- Terminated
- 2014-01-31
- Reason
- Potential malfunction when using syngo.plaza. On syngo.plaza workplaces large studies can be loaded into the viewer if transferred from a DICOM node or imported even while image transfer is not yet completed. In these situations more images of that study may exist which are not shown in the syngo.plaza viewer.
- Root cause
- Software design
- Action
- Siemens Medical Solutions USA sent a Customer Safety Advisory Notice dated March 10, 2011 to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed the customer of the potential issues and provides additional information on the implemented resolution. For further questions please call (610) 219-4834.
- Quantity
- 1
- Distribution
- Nationwide Distribution New York
- Lot, serial or model codes
- Model number 10592457
- 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