| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01355-1 |
| Product Name/Description |
SOMATOM Definition AS, Definition, Definition Edge, Definition Flash and SOMATOM Force
Catalogue Numbers: 7740769, 8098027, 10590000, 10430603 and 10742326
ARTG Number: 274034 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified a potential risk of unnecessary radiation exposure due to a software issue in the CARE Dose4D algorithm implemented in specific Siemens CT scanners. This relates to possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate. Potentially, the CARE Dose4D software will select the maximum tube current for the uppermost part of the skull, thus leading to unnecessary radiation exposure.
The described issue will not occur when using a lateral topogram instead of a p.a. or an a.p. topogram. Accordingly, Siemens strongly recommends using topograms in lateral position for all head scans. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users that the described issue will not occur when using a lateral topogram instead of a.p.a. or an a.p. topogram. Accordingly, Siemens strongly recommends using topograms in lateral position for all head scans.
Siemens will be providing a software update as a permanent correction.
This action has been closed out on 27/02/2019 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |