Z-0948-2013Class II

Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed...

Name: Z-0948-2013 Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed...
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-11-27
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-11-27 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system on 2012-11-27. FDA classified it as Class II and gives the reason as "Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0948-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-27
Posted: 2013-03-14
Terminated: 2014-01-31
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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.
Root cause tag: software
FDA 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 in commerce: 896
Distribution: Nationwide Distribution.
Product codes and lots: Model numbers - 7740769, 8098027, 10430603, and 10590000.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0948-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0948-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-14

Product code JAK

K122471Class IISomatom DefinitionSiemens Medical Systems, Inc. / cleared 2012-09-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)