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Recall Observatory FDA recall evidence

Device product

MEVION S250 for Proton Radiation Therapy

Z-1529-2016

March 15, 2016

Class II

Product summary

Firm
Mevion Medical Systems, Inc.
Event
Event 73602
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-1529-2016

Official wording

Reason: Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death.

Code information: S250-0002

Distribution pattern: US nationwide distribution to MO, OK, FL, and NJ.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death.