Device product
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Z-1481-2014
Product summary
- Event
- Event 67535
- Status
- Terminated
- Classification
- Class II
- Quantity
- 251 units (148 units domestically & 103 units internationally)
- Official record key
device-enforcement:Z-1481-2014
Official wording
Reason: RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.
Code information: Versions: 2.0.0.15, 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9.
Distribution pattern: Worldwide Distribution - USA Nationwide in the states of: AZ, CA, CT, CO, DE, FL, IL, NJ, NY, MA, MD, MS, OH, PA, TN, VA and WA. and the countries of Australia, New Zealand, Belgium, New South Wales, Republic of Korea, Italy, Germany, China, France, Switzerland, Netherlands, Spain, Austria, United Kingdom and Norway.
Derived failure modes
-
Unknown
RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.