FDA recall Z-2540-2020

FHC, Inc. · Class II · device

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

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-06-17
Report date
2020-07-15
Termination date
2020-11-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bowdoin, ME, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2540-2020