Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15008 |
| Brand Name: | RaySearch RayStation - Radiation therapy treatment planning system |
| Model: | |
| Affected: | |
| Software version: | 3.0 and 3.5 |
| Recalling Organisation: | CARSL Consulting 30 Fulford Road Havelock North 4130 Hastings |
| Contact Information: | 09 238 3447 |
| Manufacturer: | RaySearch Laboratories AB (publ) |
| Issue: | As issue has been identified in the RayStaion 3.0 and 3.5 dose volume statistics calculation. Under certain conditions resampling of regions of interest (ROI) geometries to the dose grid representations is not correctly calculated and an additional voxel layer is added incorrectly on the superior side of each ROI. The problem is pronounced for very small ROIs, leading to a possible over estimation of the dose maximum or a possible under estimation of the dose minimum, thus always erring on the safe side. Worst-case scenario is delivering less dose than optimal to target organs. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/7/2013 |
