FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
- Recall number
- Z-0948-2013
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
- Status
- Terminated
- Initiated
- 2012-11-27
- Posted
- 2013-03-14
- Terminated
- 2014-01-31
- Reason
- Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.
- Root cause
- Software design
- Action
- Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" dated November 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The correction for this problem will be available with Service Pack 1 for syngo CT2011A And Service Pack 4 for syngo CT2012B. Both Service pack are planned to be released starting February 2013. Systems still running on syngo CT2010A or syngo CT2010B are already scheduled to be upgraded to syngo CT2011A or syngo CT2012B respectively. Contact your local Siemens Application Specialist for additional information.
- Quantity
- 896
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Model numbers - 7740769, 8098027, 10430603, and 10590000.
- 510(k) numbers
- ["K122471"]
- PMA numbers
- not on file
- Product code
- JAK
- 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