BEUDAMED
    FDA Enforcement Class II Terminated

    FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740

    Recall: Z-2540-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2540-2020
    Event ID
    85897
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    FHC, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2020
    Initiation Date
    June 17, 2020
    Classification Date
    July 8, 2020
    Termination Date
    November 2, 2020
    Address
    1201 Main St, Bowdoin, ME, 04287-7302, United States

    Description

    FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740

    Reason

    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.

    Code Info

    Serial Numbers: 45695, 48871, 48873, 48874, 46195, 46198

    Distribution

    US Nationwide distribution including in the states of CA, NC, TN, TX, WA.

    Quantity

    6 units