Reported Apr 27, 2016 · Terminated

MEVION S250 for Proton Radiation Therapy

Mevion Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mevion Medical Systems, Inc. · 300 Foster Street · Littleton, MA · 01460-2017

Is this the product you have?

  • MEVION S250 for Proton Radiation Therapy
Lot codes and dates
  • S250-0002
Amount recalled
5

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 24, 2017 · Data as of Sep 19, 6:02 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.