FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: syngo Imaging XS, all versions Radiological image processing system
- Recall number
- Z-0514-2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- syngo Imaging XS, all versions Radiological image processing system
- Status
- Terminated
- Initiated
- 2011-09-20
- Posted
- 2012-01-11
- Terminated
- 2014-03-05
- Reason
- Unintended behavior when using syngo Imaging XS, all versions. The "Rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system.
- Root cause
- Labeling False and Misleading
- Action
- Siemens Medical Solutions USA, Inc sent a Customer Safety Advisory Notice letter dated August 3, 2011 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you detect patient data inconsistencies in your system caused by this problem, please contact Siemens Service for support. For further questions please call (610) 219-4834.
- Quantity
- 38
- Distribution
- Nationwide Distribution including the states of CA, FL, GA, IN, IA, KS, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
- Lot, serial or model codes
- Model number 10496279
- 510(k) numbers
- ["K082430"]
- 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