RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
- Recall Initiated
- April 7, 2021
- Terminated
- June 2, 2023
- Recall Number
- Z-1598-2021
Reason for Recall
When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.
Distribution
Domestic: TN
Lot / Code Info
Software version number: 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 , 10.1.0.613
Root Cause
Software design
Action Taken
On 04/08/2021, Gore issued an Urgent Medical Device Removal notice to customer via letter notifying them that a Gore Viabil Biliary Endoprosthesis 10 mm x 10 cm device appeared shorter than the labeled length.