Device product
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
Z-1275-2018
Product summary
- Event
- Event 79582
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2484
- Official record key
device-enforcement:Z-1275-2018
Official wording
Reason: Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
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
Distribution pattern: Nationwide
Derived failure modes
-
Device software or design
Software issue with Center Beam in Field functionality. Issue