| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00608-1 |
| Product Name/Description |
MOSAIQ versions 2.41 and higher
(Oncology information system used to manage workflows for treatment planning and delivery)
Sites affected will be those meeting ALL three criteria below:
1) Running MOSAIQ Release 2.41 and higher
2) With at least one linac equipped with an Agility 160 multi-leaf collimator (MLC) head (Versa HD, Infinity, Axesse (EOS) or Synergy)
3) Who are treating with Stereotactic Cones
ARTG: 206321 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/07/2015 |
| Responsible Entity |
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| Reason/Issue |
A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans. When a stereotactic field is imported or promoted, and the Treatment Field Definition is opened:
- The MLC shape will be correct for the planned cone field size, and
- The user will also see the field size displayed with X=40 and Y=the jaw setting for the planned cone.
If Simple MLC is selected, without changing the jaw size, the MLC shape will move the virtual X jaw to its most retracted position of 40. When the user clicks “OK” to accept the field change, they are presented with the Field Delta window and they must click “Accept” for the change to take effect. If the MLCs are not edited to return to the correct shape for the planned cone, the user can unintentionally save the virtual jaw settings as the MLC shape resulting in a treatment field much larger than intended. The problem occurs because Simple MLC is resetting the MLC positions. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The problem can be avoided by clicking Cancel on the Create Simple MLC window, editing the field size values in the Create Simple MLC window to return to the correct MLC shape for the planned cone before saving or by not using the Simple MLC view. This problem will be resolved in a future release of the current MOSAIQ versions 2.41, 2.50, 2.60, 2.62. Elekta will inform the affected customers when the relevant MOSAIQ build is released containing the fix. This action has been closed-out on 8/08/2016, |
| Contact Information |
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