FDA recall Z-0705-2019
Mevion Medical Systems, Inc. · Class II · device
Product
MEVION S250i
Reason for recall
Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped
Distribution
DC
Key facts
- Status
- Terminated
- Initiation date
- 2018-10-01
- Report date
- 2019-01-16
- Termination date
- 2020-04-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Littleton, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0705-2019