Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:17182
Brand Name:Elekta Focal Radiation Therapy Treatment Planning Systems
Model:
Affected:
Software version:Focal 4.7 and 4.8 when using Elekta or Siemens linacs
Recalling Organisation:Elekta Pty Limited - New Zealand Branch
Suite 302, Geyser Building, 100 Parnell Road
Parnell
AUCKLAND 1052
Contact Information:0273-544-793
Manufacturer:Elekta Inc
Brand Name:Elekta Monaco Radiation therapy treatment planning system
Model:
Affected:
Software version:Monaco 3.20.00 and higher when using Elekta or Siemens linacs
Recalling Organisation:Elekta Pty Limited - New Zealand Branch
Suite 302, Geyser Building, 100 Parnell Road
Parnell
AUCKLAND 1052
Contact Information:0273-544-793
Manufacturer:Elekta Inc
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.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:15/8/2014
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