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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01433-1
Product Name/Description SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic system)

Catalogue Numbers: 8098027, 10430603

ARTG Number: 274034
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 3/11/2016
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue The small light marker window used for the positioning laser and integrated in the front cover of the CT that had loosened in the past and had been subsequently fixed, could now become loose again and potentially drop out. In this case, there is a risk that a person could touch rotating or electrical parts of the gantry when reaching through the window opening. There is a risk for serious injury e.g. by electrical shock or physical harm to fingers.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is developing a solution for the problem and this will be implemented as a permanent correction. In the interim, users should maintain awareness until a solution is implemented. They should not use the CT system in case a light marker window is missing or loose and is advised to inform the Siemens Service immediately.

This action has been closed out on 07/11/2018
Contact Information 1800 310 300 - Siemens Customer Care Centre