FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
- Recall number
- Z-2275-2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
- Status
- Terminated
- Initiated
- 2012-07-18
- Posted
- 2012-08-27
- Terminated
- 2014-01-24
- Reason
- There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.
- Root cause
- Software design
- Action
- The firm initiated their recall/correction of this device on July 18, 2012 by sending a "Customer Safety Advisory Notice" letter, dated July 12, 2012, to their consignees. The letter identified the affected product along with the malfunction. It also discussed the steps the user can take to avoid the issue. Users were asked to not use the mentioned functions for images from those modalities until the issue was resolved and the system was updated with the software version containing the solution. Users were to contact their local Siemens Service in order to plan for the updated software version that will resolve the issue. Additionally, users should place the safety advisory notice in the system's instructions for use, and personnel should be instructed accordingly and maintain awareness. If the device was sold and is no longer in the users' possession, the notice should be forwarded to the new owner and the firm should be notified of the new owner.
- Quantity
- 14
- Distribution
- Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
- Lot, serial or model codes
- Serial Numbers: 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, & 100146.
- 510(k) numbers
- ["K101666"]
- 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