Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2540-2020 — 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

U.S. FDA — Device Enforcement · United States · 2020-06-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2540-2020
Date of alert
2020-06-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
FHC, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00873263006740
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.