Reported Mar 12, 2014 · Terminated

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product…

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?

  • All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility
  • or Asymmetric Heads Product UsageDeliver of radiation to defined target volumes
Lot codes and dates
  • 471 of 471 codes

    • 151855
    • 151587
    • 152246
    • 151694
    • 152019
    • 105864
    • 151729
    • 105932
    • 151574
    • 152397
    • 152559
    • 152248
    • 151875
    • 153036
    • 153072
    • 151965
    • 151076
    • 151363
    • 152448
    • 105782
    • 151110
    • 105841
    • 105731
    • 105989
    • 152154
    • 151093
    • 151369
    • 105727
    • 151705
    • 151954
    • 152502
    • 152454
    • 152262
    • 151504
    • 105941
    • 151418
    • 105990
    • 151674
    • 105555
    • 151399
    • 105809
    • 151802
    • 105610
    • 151134
    • 151421
    • 105716
    • 105717
    • 152427
    • 105829
    • 153035
    • 105910
    • 152117
    • 152803
    • 151566
    • 151033
    • 152271
    • 151736
    • 151700
    • 151866
    • 151259
Amount recalled
472 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

Customers are resetting the default values outside recommended factory settings.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 15, 2021 · Data as of Sep 19, 5:21 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.