Device product
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Z-1308-2014
Product summary
- Event
- Event 67511
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 units (16 units domestically & 3 units internationally)
- Official record key
device-enforcement:Z-1308-2014
Official wording
Reason: RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
Code information: Model#: 4.30; Version: 4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses
Distribution pattern: OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,
Derived failure modes
-
Unknown
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.