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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00896-1
Product Name/Description Monaco and Focal (radiation treatment planning systems)

Monaco: versions 3.20.00 and higher
Focal: versions 4.70 & 4.80

ARTG numbers: 215960 & 186853
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 14/08/2014
Responsible Entity Elekta Pty Ltd
Reason/Issue When DICOM exporting an arc plan (VMAT, Dynamic Conformal or 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.

The problem occurs when the starting gantry angle of the second arc is exactly 180 degrees and the stop angle of first beam is greater than 180 degrees away from the start position of the second arc. CFS is designed to combine arcs into a single beam to streamline delivery. However, under these specific circumstances, the start and stop points for the arcs become corrupted.

Sites affected will be those:
1. Running Monaco Release 3.20 and higher, and
2. With Elekta or Siemens LINACs, and
3. With any of the following licenses: VMAT or Dynamic Conformal or 3D (static arcs), and
4. Using CFS when DICOM exporting plans.
Customers with Focal Releases 4.70 and 4.80 are also affected by this issue when Focal is used with Monaco and meet the criteria above.
Recall Action Recall for Product Correction
Recall Action Instructions Elekta is advising that to avoid the problem, do not use 180 degrees for the starting gantry angle of the second arc. Using 180.1 or 179.9 degrees as the starting gantry angle will completely avoid this issue. The problem will be resolved in updates to Monaco and Focal software i.e., Monaco 3.30, Monaco 5.00, and Focal 4.80. The expected release date is September 30, 2014. This action has been closed-out on 04/08/2016.
Contact Information 02 8907 1800 - Elekta Pty Ltd