Z-1275-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- January 26, 2018
- Termination Date
- January 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2484
Product Description
Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130
Reason for Recall
Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
Distribution Pattern
Nationwide
Code Information
Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19