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Recall Observatory FDA recall evidence

Device product

MEVION S250 Product Usage: Proton Radiation Therapy System

Z-0410-2017

October 21, 2016

Class II

Product summary

Firm
Mevion Medical Systems, Inc.
Event
Event 75498
Status
Terminated
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0410-2017

Official wording

Reason: Recovery of Incorrect Isocenter -operational change

Code information: Serial Number: S250-0001 through S250-0006

Distribution pattern: US Nationwide Distribution in the states of FL, MO, NJ, OH and OK,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Recovery of Incorrect Isocenter -operational change