Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17910 |
| Brand Name: | Elekta Monaco Focal Images Statistics Tool |
| Model: | Monaco |
| Affected: | |
| Software version: | 4.80.00 |
| 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 a CT phantom is scanned and the images are transferred to Focal, it is possible to sample the densities using the Image Statistics tool in Focal. In the case where CT slice thickness is not the same as CT slice spacing the Image Statistics tool will report an incorrect HU. If the user bases their CT to ED file on this incorrect density information, dose calculation errors will result. The magnitude of the dose calculation error will be dependent on the magnitude of the HU error. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/12/2014 |
