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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00654-1
Product Name/Description Biograph, Symbia T and Symbia Intevo SPECT/CT systems

Catalogue Numbers: 8728581, 10097303, 10097289, 10097302, 10532746, 10532748, 10528958, 10529158, 10529160, 10529161, 10528955, 10507786, 10507786, 10534160, 10248669, 10248672, 10248673, 10248670, 10525581, 10764804, 10764802, 10764803, 11007962, 10764801, 10275007, 10275010, 10275008, 10275009 and 8717733.

ARTG Numbers: 123883, 144218 and 271560.
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 5/06/2018
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens Healthineers are aware of potentially incorrect tube-current calculations by the CARE Dose4D algorithm when utilising only PA or AP topograms. Depending on the geometrical shape of the skull, rare cases may occur in which the calculated dose distribution is not appropriate for scans that include the head, when based only on PA or AP topograms. The CARE Dose4D software may select the maximum tube current for the uppermost part of the skull, which incidentally leads to unnecessary radiation exposure.
Recall Action Product Defect Correction
Recall Action Instructions Siemens is advising that the manufacturer is developing appropriate solutions to address the problem with high priority.

The described issue does not occur when using a lateral topogram. Accordingly, Siemens strongly recommend the utilisation of topograms in the lateral position for all CT and PET/CT scans that include the entire head.
Alternatively, if users choose to perform both a lateral topogram, in conjunction with a PA or AP topogram they must ensure that they perform the lateral topogram last as CARE Dose4D is based on the last topogram. If users do not utilise a lateral topogram for scans including the entire head, Siemens strongly recommends that users deactivate the CARE Dose4D feature.

This action has been closed out on 25/05/2021
Contact Information 1800 310 300 - Siemens Customer Care Centre