Z-1930-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2019
- Initiation Date
- November 20, 2017
- Termination Date
- August 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 744
Product Description
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
Reason for Recall
When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
Distribution Pattern
US Nationwide Distribution
Code Information
Software versions: 3.5.0.16 , 3.5.1.6 , 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35 , 5.0.3.17 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 and 6.2.0.7