Reported Aug 8, 2018 · Terminated

Nicolet¿ Ambulatory EEG

Natus Neurology 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: Natus Neurology Inc · 3150 Pleasant View Rd · Middleton, WI · 53562-4800

Is this the product you have?

  • Nicolet¿ Ambulatory EEG
Lot codes and dates
  • 169 of 169 codes

    • UDI 00382830043670
    • Serial Numbers MBR120693
    • MBR100549
    • MBR100566
    • MBR120699
    • MBR090299
    • MBR090317
    • MBR150907
    • MBR100541
    • MBR120700
    • MBR120681
    • MBR120686
    • MBR120697
    • MBR130793
    • MBR110634
    • MBR150920
    • MBR150921
    • MBR160934
    • MBR120665
    • MBR110629
    • MBR090308
    • MBR150885
    • MBR090327
    • MBR120720
    • MBR130784
    • MBR130785
    • MBR120696
    • MBR100579
    • MBR090318
    • MBR150928
    • MBR100610
    • MBR110642
    • MBR090313
    • MBR100578
    • MBR100564
    • MBR100626
    • MBR120683
    • MBR100594
    • MBR090324
    • MBR090326
    • MBR090329
    • MBR100583
    • MBR100602
    • MBR100603
    • MBR100624
    • MBR120659
    • MBR120674
    • MBR100567
    • MBR140853
    • MBR100565
    • MBR110645
    • LBR06094
    • LBR06095
    • LBR06101
    • MBR120660
    • MBR100550
    • MBR120671
    • MBR150886
    • MBR150890
    • MBR150893
Amount recalled
171 units

Where it was sold

Why it was recalled

Potential to be able to import an ambulatory exam for a patient for which the exam was not started.

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 Oct 21, 2022 · Data as of Sep 19, 5:28 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.