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Recall Observatory FDA recall evidence

Device product

MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy

Z-1122-2017

December 16, 2016

Class II

Product summary

Firm
Mevion Medical Systems, Inc.
Event
Event 76090
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-1122-2017

Official wording

Reason: An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened

Code information: S250-0002 and S250-0003

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened