Reported Feb 17, 2016 · Terminated

MEVION S250 Radiation therapy system

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 Radiation therapy system
Lot codes and dates
  • Manufacturing Lot or Serial NumberS250-0004
Amount recalled
4

Where it was sold

Why it was recalled

The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.

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, 2017 · Data as of Sep 19, 6:00 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.