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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01298-1
Product Name/Description SOMATOM CTs: Definition Flash, Definition Edge, Definition AS and Definition (full body CT diagnostic x-ray systems) equipped with software syngo CT2010A, CT2010B, CT2011A and CT2012B

ARTG Number: 164065
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/01/2013
Responsible Entity Siemens Ltd
Reason/Issue There is a sporadic malfunction concerning 3D reconstructions during activated "Preview Image" functionality. The problem may occur during the process of 3D recon job planning and editing within the "Examination" card while the "Preview Image" functionality is activated; when switching then to another recon job the system might sporadically hang up.
Recall Action Recall for Product Correction
Recall Action Instructions The customer letter identifies the software workarounds to mitigate the problems temporarily. Siemens will schedule software upgrades shortly for mitigating the problems permanently.
Contact Information 1800 310 300 - Siemens Regulatory Affairs