Reported Dec 20, 2017 · Terminated

Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.

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 · 13723 Riverport Dr Ste 100 · Maryland Heights, MO · 63043-4819

Is this the product you have?

  • Elekta ERGO++
  • Product UsageERGO is often used for stereotactic treatments
Lot codes and dates
  • Version 1.7.3 and higher
Amount recalled
182

Where it was sold

Why it was recalled

Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.

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, 5:33 PM UTC

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