Raysearch_raystation_ablation Therapy
RayStation Ablation Therapy Recall Summary RaySearch's RayStation software (versions 4.7 through 2026, including some service packs) is being recalled because of a dose deformation issue where parts of expanded doses can extend beyond the dose grid boundary and be lost during calculations. No patient harm has occurred, but clinicians need to be aware that deformed doses used in further evaluation or planning may underestimate the actual radiation dose. This recall affects medical facilities in New Zealand using this software for ablation therapy planning.
- Recalling firm
- CARSL Consulting
- Product
- RaySearch_RayStation_Ablation therapy. [Device]. Model: RayStation 4.7 to v2026, including some service packs
- Reason
- The manufacturer has identified an issue with dose deformation. When a dose is deformed using a deformable registration that expands outwards near the boundary of the original dose grid, parts of the deformed dose may extend beyond the boundary, meaning clinically relevant dose may be lost. The issue has not caused any patient mistreatment. However, the user must be aware of the information in this notice to avoid unintended underestimation of dose when using the deformed dose for further evaluation or planning.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-10-06
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/a417ac21-f213-49e4-90dc-b68f3d69dbbd