Reported Feb 12, 2014 · Terminated

XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or…

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. · 400 Perimeter Center Ter Ne · Atlanta, GA · 30346-1227

Is this the product you have?

  • XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Lot codes and dates
  • MUJ
Amount recalled
1424

Where it was sold

Why it was recalled

When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.

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 Dec 2, 2015 · Data as of Sep 19, 5:37 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.