FHC, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2540-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product 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

Product Classification:

Class II

Date Initiated: June 17, 2020

Date Posted: July 15, 2020

Recall Number: Z-2540-2020

Event ID: 85897

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.

Status: Terminated

Product Quantity: 6 units

Code Information:

Serial Numbers: 45695, 48871, 48873, 48874, 46195, 46198

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated