FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens syngo.plaza. Radiological image processing system
- Recall number
- Z-2078-2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens syngo.plaza. Radiological image processing system
- Status
- Terminated
- Initiated
- 2012-02-24
- Posted
- 2012-07-26
- Terminated
- 2014-01-14
- Reason
- Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.
- Root cause
- Software design
- Action
- Siemens sent a Customer Safety Advisory Notice letter dated February 24, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to ensure that the prefix defined in the viewer settings for "Content Creator's Initials" is not empty. Then all images will be display correctly. This has to be checked for every user. Further questions please call 610-219-6300.
- Quantity
- 2
- Distribution
- (USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
- Lot, serial or model codes
- Model number 10592457
- 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