Device product
MEVION S250, used for proton radiation therapy.
Z-0588-2015
Product summary
- Event
- Event 69778
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0588-2015
Official wording
Reason: Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.
Code information: Serial Number: S250-0001
Distribution pattern: US Distribution in the state of MO
Derived failure modes
-
Device software or design
Software defect that causes an incorrect