# FDA recall Z-2540-2020

> **FHC, Inc.** · Class II · device recall initiated 2020-06-17.

## 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

- **Recall number:** Z-2540-2020
- **Recalling firm:** FHC, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2540-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2540-2020. Source: US FDA. Licensed CC0.

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