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TGA Action ID RC-2026-RN-00825-1
Type of Product Medical Device
Product Name/Description RayStation 4.7 to v2026 including some service packs

Multiple models and build numbers
ARTG Number 195288
Unique Device Identifier (UDI) See Customer Letter
Action Type Product Correction
Action Level Hospital
Hazard Classification Class II
Reason for the Action In RayStation, a dose distribution calculated on one image set can be mapped to another using deformable registration. This can be useful when evaluating the effect of a previously delivered dose when planning new treatment.

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 excluded from the deformed dose distribution. If this deformed dose is subsequently used as background dose, the missing dose contribution will be treated as zero dose, potentially resulting in an underestimation of the accumulated dose.

This situation requires substantial anatomical differences between the reference and target image sets. Examples include significant weight gain, growth in paediatric patients, or other anatomical changes that increase the extent of the anatomy beyond the region covered by the original dose grid.

For reirradiation planning, the problem may lead to underestimation of the accumulated dose to organs at risk. For adaptive planning, it may lead to underestimation of the accumulated dose to the target and/or organs at risk.
Instructions for Customers/Users Customers are to:
· Exercise caution when deforming dose using a deformable registration that is expanding outwards in the region close to the boundary of the original dose grid.
· Review deformed dose carefully before using it for dose accumulation or treatment evaluation.
· Ensure that the dose grid extends with a sufficient margin around regions where the deformable registration may expand outward.

The problem will be resolved in RayStation v2026 SP1, expected to be available in February 2027.
Action Commencement Date 15/10/2026
Responsible Entity Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Contact Information AUNZvigilance@ul.com - Emergo Australia