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

Recall date

June 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2540-2020

FDA classification

Class II

Brand / firm

FHC, Inc.

Sold / distributed

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

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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