Reported Jul 15, 2020 · Terminated
FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological…
FHC, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: FHC, Inc. · 1201 Main St · Bowdoin, ME · 04287-7302
Is this the product you have?
- FHC Guideline 4000 5.0 GL5
- Main Processing Unit - Product Usageintended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments
- Catalogue NumberC0215
- UDI00873263006740
- Lot codes and dates
- Serial Numbers
456954887148873488744619546198
- Serial Numbers
- Amount recalled
- 6 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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