FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions, USA, Inc: syngo Dynamics Version 9.5
- Recall number
- Z-2219-2012
- Recalling firm
- Siemens Medical Solutions, USA, Inc
- Product
- syngo Dynamics Version 9.5
- Status
- Terminated
- Initiated
- 2012-07-13
- Posted
- 2012-08-17
- Terminated
- 2013-07-15
- Reason
- If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study.
- Root cause
- Software design
- Action
- On 07/13/2012, Siemens issued a "Customer Safety Advisory Notice" to affected consignees according to Update Instruction SY062/121S. The notice informs the customers of the potential issue with the identified affected product and provides details regarding the resolution. A software update to relieve the symptom of the issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY063/121S. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY064/121S.
- Quantity
- 30
- Distribution
- Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.
- Lot, serial or model codes
- 10091862 and 10091863
- 510(k) numbers
- ["K102150"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3003304172
- Firm city
- Ann Arbor
- Firm state
- MI
- 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