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
FDA Recall Z-2540-2020 · Posted None
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Recalling FirmFHC, Inc.
Recall StatusTerminated
Product CodeGZL
Date Initiated2020-06-17
Date Terminated2020-11-02
Product Quantity6 units
Reason for Recall
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.
Firm 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.
Root Cause
Component change control
Distribution Pattern
US Nationwide distribution including in the states of CA, NC, TN, TX, WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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