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FHC, Inc. recalls FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological
Recalled July 15, 2020 · FDA recall Z-2540-2020 · FHC
Hazard
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. · FDA Class II
Units
6 units
Sold at
US Nationwide distribution including in the states of CA, NC, TN, TX, WA.
Description
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.
Product
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
Manufacturer(s)
FHC, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →