| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00487-1 |
| Product Name/Description |
SOMATOM Force with software version VA50A
Catalogue Number: 10742326
ARTG Number: 274034 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
An addendum is to be added to the Instructions For Use (IFU) of the SOMATOM Force system with software version VA50A which is related to the use of the Turbo Flash Mode with very short scan ranges. When selecting the Turbo Flash Mode in combination with a spiral scan length of less than 27 mm the image reconstruction will possibly fail for this scan. As a workaround the addendum states for the Turbo Flash Mode to always select a spiral scan length higher than 27 mm or to switch to another mode instead. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users to always select a spiral scan length higher than 27mm or to switch to another mode when selecting the Turbo Flash Mode in combination with a spiral scan length of less than 27mm. (This information is contained in the addendum which will be posted to users). Users are requested to place this addendum in their User Manual and to disseminate the information to the relevant personnel at their organisation.
This action has been closed-out on 23/03/2018. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |