Reported Aug 16, 2017 · Terminated

iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a…

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 Ste 50 · Atlanta, GA · 30346-1227

Is this the product you have?

  • iGUIDE Software 2.2
  • Product UsageControl of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment
Lot codes and dates
    • Scope
    • iGUIDE 2.2.0
    • iGUIDE 2.2.1
Amount recalled
110 units

Where it was sold

Why it was recalled

Incorrect PEC values.

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 5, 2019 · Data as of Sep 19, 6:04 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.