The Recall Desk
ModerateFDA (Devices)·Z-2540-2020·Announced 2020-07-15

FHC Guideline 4000 5.0 Main Processing Unit Recalled for Electrical Defect

FHC, Inc. is recalling six Guideline 4000 5.0 Main Processing Units because an electrical sub-circuit was not properly connected, potentially affecting performance during ESD events.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential performance interference during an ESD event, which is a theoretical risk without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

FHC, Inc. is recalling six units of the FHC Guideline 4000 5.0 GL5 Main Processing Unit. The recall is due to an electrical sub-circuit that was not properly connected. This sub-circuit is intended to eliminate the possibility of interference with the proper performance of the unit if an Electrostatic Discharge (ESD) event greater than 6kV were to occur.

The affected units were distributed nationwide in the United States, including in California, North Carolina, Tennessee, Texas, and Washington. The specific serial numbers for the recalled units are 45695, 48871, 48873, 48874, 46195, and 46198. The product is intended to record and stimulate electrophysiological activity and aid in the accurate placement of electrodes and other instruments.

Users of these devices should contact FHC, Inc. for further instructions on how to address the defect. The recall is classified as Class II by the FDA.

The recalled product

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
Manufacturer
FHC, Inc.
Category
Medical Device — Electrophysiology Equipment
Hazard
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

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

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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