Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36350 |
| Brand Name: | RaySearch_RayStation_Ablation therapy |
| Model: | RayStation/RayPlan 10B, 11A, 11B, 12A, 2023B, 2024A, 2024B and v2025 |
| 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: | The manufacturer has become aware that in rare cases, the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This problem occurs for ROI(s) which has no contours and either has a material override defined, or is of type Bolus, Fixation, or Support. It only occurs for ROI(s) that have no contours defined on the image set but have a PrimaryShape. An ROI geometry can reach this state when, e.g., all contours for the ROI have been removed from an image set using a contouring tool, or when a derived ROI is updated or overridden in a way that results in an empty geometry (for example when a derived ROI is the intersection of two ROIs that have no overlap in the image set). After the dose is computed, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 5/12/2025 |
