Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14762 |
| Brand Name: | Elekta Monaco Radiation Treatment Planning System |
| Model: | |
| Affected: | All versions |
| Software version: | |
| 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: | Patients can be scanned either Head First or Feet First and these CTs imported into Monaco for radiation treatment planning. The Monaco CT Sim workflow gives an option to prepare a Feet First plan, but Monaco IMRT workflow does not. Although a patient can be scanned Feet First and these Feet First CTs imported into Monaco, the user could incorrectly assume that the intensity-modulated radiation therapy (IMRT) plan is Feet First as well. When the patient is treated, they could be incorrectly positioned in the Feet First position which will not match the plan. If the patient is positioned for treatment in the Feet First position, the IMRT treatment plan will not match what is delivered, potentially resulting in a significant beam geometry error. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 6/6/2013 |
