BEUDAMED
    FDA Recall 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 · Initiated June 17, 2020

    Recall

    Recall Number
    Z-2540-2020
    Event Number
    85897
    Firm
    FHC, Inc.
    FEI Number
    3002250546
    Product Code
    GZL
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    June 17, 2020
    Terminated
    November 2, 2020
    Address
    1201 Main St, Bowdoin, ME, 04287-7302

    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.

    Action

    FHC issued Urgent Medical Device Recall letter dated 6/17/20 via USPS certified return receipt,stating reason for recall, health risk and action to take: FHC, Inc. field representatives will be contacting you to return the effected product and issue a replacement. In the interim, we advise you to stop use of this product. Should you have any further questions regarding this matter you may contact me, by email at [email protected] or by telephone at 207-666-5425.

    Distribution

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

    Quantity

    6 units