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Recall Observatory FDA recall evidence

Device product

MEVION S250i

Z-0705-2019

October 01, 2018

Class II

Product summary

Firm
Mevion Medical Systems, Inc.
Event
Event 81751
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0705-2019

Official wording

Reason: Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped

Code information: DI: (01)00864366000124 Serial Number: S250i-0007

Distribution pattern: DC

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped