—#115965

Product

Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K122471
Affected lot / code info: Model numbers - 7740769, 8098027, 10430603, and 10590000.

Why it was recalled

Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2012-11-27
Posted by FDA: 2013-03-14
Terminated: 2014-01-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115965. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.