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Terminated

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

FDA Recall Z-0948-2013 · Posted 2013-03-14

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2012-11-27
Date Terminated2014-01-31
Product Quantity896

Reason for Recall

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

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122471SOMATOM DEFINITIONSiemens Medical Systems, Inc. · 2012-09-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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