FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens syngo.plaza image processing system image processing radiological system
- Recall number
- Z-0271-2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens syngo.plaza image processing system image processing radiological system
- Status
- Terminated
- Initiated
- 2011-08-08
- Posted
- 2013-11-13
- Terminated
- 2014-11-06
- Reason
- The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems.
- Root cause
- Software design
- Action
- Siemens sent a Customer Safety Advisory Notice dated August 3, 2011, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to forward the Customer Safety Advisory Notice to their customers. If necessary, customers should have the letter translated technically into the local language and copy it themselves. A letter was sent to direct accounts to inform them of the issu and provide instructions to avoid encountering the problem. For questions regarding this recall call 610-219-6300.
- Quantity
- 19
- Distribution
- Nationwide Distribution including MO, MA, NY, WI, OH, NY, CA, FL, NC, MN, and WA.
- Lot, serial or model codes
- Model Number 10592457 with serial numbers 100263, 100177, 100138, 100174, 100005, 100006, 100007, 100008, 100009, 100010, 100219, 100201, 100198, 100181, 100249, 100301, 100302, 100157, 100146
- 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