Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20610 |
| Brand Name: | RaySearch Radiation Therapy Treatment Planning System |
| Model: | 2.5, 3.0, 4.0, 4,5, 5.0 and 4.3 and InverseArc 1.0 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | CARSL Consulting 30 Fulford Road Havelock North 4130 Hastings |
| Contact Information: | 09 238 3447 |
| Manufacturer: | RaySearch Laboratories AB (publ) |
| Issue: | Two issues have been identified with the dose calculation when using a region of interest (ROI) of type Fixation or Support with material override within the patient outline in RayStation models. 1. When an ROI with material override overlaps a Fixation or Support ROI, the material used for dose calculation in the overlapping region may not be as intended. 2. When a Support or Fixation ROI overlaps the patient outline (External ROI) in a dose grid voxel along the outer surface of the patient outline, the density used for dose calculation in that voxel may not be as intended. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 6/9/2016 |
