Device product
MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Z-1271-2014
Product summary
- Event
- Event 67657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1271-2014
Official wording
Reason: Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields
Code information: S250-0001
Distribution pattern: USA Nationwide Distribution in the state of MO
Derived failure modes
-
Unknown
Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields