Reported Sep 14, 2016 · Terminated

Medical Linear Accelerator

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?

  • Medical Linear Accelerator
Lot codes and dates
  • 553 of 553 codes

    • 105639
    • 105652
    • 105608
    • 151187
    • 151401
    • 105792
    • 105570
    • 151577
    • 151563
    • 151562
    • 151444
    • 151347
    • 151746
    • 105557
    • 151434
    • 105801
    • 151702
    • 151052
    • 151384
    • 151661
    • 105873
    • 151138
    • 105875
    • 151606
    • 151246
    • 151649
    • 105729
    • 151642
    • 105820
    • 151097
    • 151063
    • 105857
    • 105952
    • 151227
    • 151208
    • 105935
    • 151345
    • 151120
    • 151057
    • 151018
    • 105684
    • 151122
    • 105573
    • 105973
    • 105688
    • 105768
    • 151078
    • 105908
    • 151039
    • 151323
    • 105953
    • 151607
    • 151023
    • 151164
    • 151304
    • 105569
    • 105900
    • 151070
    • 151293
    • 151548
Amount recalled
553

Where it was sold

Why it was recalled

There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

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 24, 2017 · Data as of Sep 19, 4:48 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.