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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01103-1
Product Name/Description RayStation 3.0, 3.5, or 4.0 (Radiation therapy treatment planning system)

ARTG Number: 195288
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 25/10/2013
Responsible Entity Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue A dose calculation error has been identified in RayStation versions 3.0. 3.5, and 4.0, when Elekta motorised wedges are used for a beam and the wedge angle differs from 60 degrees. The error is that the modified energy spectrum has been used not only for the wedged part of the beam but also for the open part of the wedged field. For all clinical cases investigated by the manufacturer, the deviations were at the most 3-5% in the clinically relevant areas of the plan. Deviations in the 10-12% range may occur in the buildup regions where dose calculations are generally considered approximate.
Recall Action Recall for Product Correction
Recall Action Instructions The issue will be resolved in RayStation patch 4.0.2 scheduled for market release in December 2013 and in all future releases. In the interim, workarounds for creating a beam with Elekta motorized wedge, without and with wedge optimization in described in the customer letter.
Contact Information 02 9006 1662 - Emergo Australia