FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.
- Recall number
- Z-0827-2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.
- Status
- Terminated
- Initiated
- 2011-05-01
- Posted
- 2012-01-20
- Terminated
- 2014-01-24
- Reason
- The firm has become aware of the potential for an unintended merge of multiple patients when using syngo.plaza version VA20 with Server Farm setup integrated to a RIS. Sporadically it can happen that certain Patient IDs in the database are deleted and sent to NULL. This can cause incorrect merging with patients that already had a NULL Patient ID.
- Root cause
- Software design
- Action
- The firm initiated their product recall in May 2011 by issuing a "Customer Safety Advisory Notice" informing all customers of the malfunction and providing instructions on how to avoid the error. The issue will be solved with the next version release, planned for June 2011.
- Quantity
- 3
- Distribution
- Nationwide Distribution - Including the states of Florida, Massachusetts and Wisconsin.
- Lot, serial or model codes
- Model number 10592457, serial numbers 100174, 100177, and 100181.
- 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