| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00836-1 |
| Product Name/Description |
MOSAIQ and Treating on linear accelerators with the RATM license
Elekta Reference Number: FCA-IMS-0024
ARTG Number: 225164
(Elekta Pty Ltd - Information system software, application program, patient record) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
The Machine Characterization (MAC) file is instrumental to the correct operation of MOSAIQ and your Elekta Linac. Elekta has become aware of the potential for incorrect characterization of couch values, which will lead to incorrect table movements when using Couch Move Assistant (CMA). If the MAC file is set up incorrectly it is possible that table shifts can be made in the wrong direction. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is requesting the following:
1. If you are using the Couch Move Assistant (CMA) feature in MOSAIQ , run the verification test(s) given in the Customer Letter to ensure that your table is operating correctly;
2. Users should only run the tests applicable to your clinical workflows on all of your Elekta linacs that are configured for CMA;
3. If the test(s) pass successfully, sign the Acknowledgement form and return the form to Elekta; and
4. If the test(s) fail contact your local Elekta Care Support Centre for assistance.
This action has been closed out on the 24/09/2018. |
| Contact Information |
02 8907 1800 Elekta Care Support Centre |