Reported Apr 2, 2014 · Terminated

MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage:…

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 St · Littleton, MA · 01460-2017

Is this the product you have?

  • MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for
  • Proton Radiation Therapy Product UsageProton Radiation Therapy
Lot codes and dates
  • S250-0001
Amount recalled
1 unit

Where it was sold

  • Nationwide
  • MO

Why it was recalled

Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields

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 Apr 3, 2014 · Data as of Sep 19, 6:47 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.