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Recall Observatory FDA recall evidence

Device 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

Z-2540-2020

June 17, 2020

Class II

Product summary

Firm
FHC, Inc.
Event
Event 85897
Status
Terminated
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-2540-2020

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.