Reported Sep 19, 2012 · Terminated

Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of…

Elekta, 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: Elekta, Inc. · 4775 Peachtree Industrial Blvd · Norcross, GA · 30092-3011

Is this the product you have?

  • Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Lot codes and dates
  • 152599 and 152678
Amount recalled
2

Where it was sold

Why it was recalled

Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.

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 Oct 6, 2014 · Data as of Sep 19, 5:24 PM UTC

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