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Recall Observatory FDA recall evidence

Device product

MEVION S250 Product Usage: Proton Radiation Therapy

Z-0409-2017

October 31, 2016

Class II

Product summary

Firm
Mevion Medical Systems, Inc.
Event
Event 75496
Status
Terminated
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0409-2017

Official wording

Reason: Completing Setup Without Program Move Complete Can Cause An Isocenter Error

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Completing Setup Without Program Move Complete Can Cause An Isocenter Error