Reported Jul 15, 2020 · Terminated

FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological…

FHC, 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: FHC, Inc. · 1201 Main St · Bowdoin, ME · 04287-7302

Is this the product you have?

  • FHC Guideline 4000 5.0 GL5
  • Main Processing Unit - Product Usageintended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments
  • Catalogue NumberC0215
  • UDI00873263006740
Lot codes and dates
  • Serial Numbers
    • 45695
    • 48871
    • 48873
    • 48874
    • 46195
    • 46198
Amount recalled
6 units

Where it was sold

Why it was recalled

An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the Guideline 5 Main Processing Unit, if an ESD event (greater than 6kV) were to occur.

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 2, 2020 · Data as of Sep 19, 6:49 PM UTC

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