Reported Oct 31, 2012 · Terminated

Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in…

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?

  • Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
Lot codes and dates
  • None as the product is software
Amount recalled
52 units

Where it was sold

Why it was recalled

During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages.

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 Nov 3, 2014 · Data as of Sep 19, 5:29 PM UTC

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