Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19289 |
| Brand Name: | Elekta Monaco Radiation Treatment Planning System |
| Model: | |
| Affected: | |
| Software version: | 5.10 and higher |
| 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: | Two identified issues: 1- In version 5.10.01, the Isodose Control 100% isodose value was linked to the Dose Normalization value so users would always have a known normalization value linked to 100% when in relative mode. This however limits the user to only one defined value available above 100%. When the 100% isodose value is edited on the isodose control, the Dose Normalization is automatically updated. If the user does not notice this update and then rescales to a relative isoline and does not read the Dose Normalization value displayed on the rescale bar, the rescale could be other than intended. 2-When the user optimizes, then changes the bolus assignment of the beams, and then selects "Calculate" (not "Optimize" again), the bolus assignment to beams can get scrambled. Beams that should have bolus assigned do not and beams that do not have bolus assigned calculate with bolus. The dose distribution and Monitor Units are incorrect for the bolus assignment of the beams. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/10/2015 |
