Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:20181
Brand Name:Elekta Monaco
Model:5.10.00
Affected:
Software version:5.11 and 5.20
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 a 3D Monaco plan and the "Composite Field sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined. This occurs when the port shape used to define or edit the MLC positions extends beyond or inside the actual jaw positions. The defect is triggered when using a workflow for Forward Planning IMRT that involves creating multiple beams for the same gantry angle with a single MLC shape defined for each beam. These beams are then exported using CFS to combine the individual 3D beams into a single IMRT beam sequence
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:23/5/2016
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