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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85897

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 17, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
FHC, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-2540-2020
Initiated
June 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
FHC, Inc.
Quantity
6 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

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Inspect official wording and provenance

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.

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.