Reported May 15, 2019 · Terminated

Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and…

Alpha Omega Engineering

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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: Alpha Omega Engineering · PO Box 810, Haavoda Street · Nazerat Illit, N/A · N/A

Is this the product you have?

  • Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
Lot codes and dates
  • Serial numbers
    • 113
    • 115
    • 116
    • 118
    • 123
    • 121
    • 125
    • 129
    • 130
    • 137
    • 138
    • 141
    • 140
    • 146
    • 149
    • 147
    • 156/04
    • 159/04
    • 163/04
    • 161/04
    • 167
    • 175/06
    • 176/06
    • 177/06
    • 180/06
    • 182/06
    • 185/06
    • 188/06
    • and 189
Amount recalled
29

Where it was sold

Why it was recalled

Stop using this product now

If cables are improperly connected, current may reach high charge density, causing tissue harm.

Using this product could cause serious injury, illness or death — stop using it now.

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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 3, 2020 · Data as of Sep 19, 4:52 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.