Z-2540-2020Class II

FHC Guideline 4000 5.0 GL5 Main Processing Unit -

Name: Z-2540-2020 FHC Guideline 4000 5.0 GL5 Main Processing Unit -
Creator: FHC, Inc.
Published: 2020-06-17
License: https://open.fda.gov/license/

FHC, Inc. / initiated 2020-06-17 / Terminated

FDA source

FHC, Inc. began a recall of 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... on 2020-06-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2540-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-17
Posted: 2020-07-08
Terminated: 2020-11-02
Recalling firm: FHC, Inc.
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
Product code: GZL Electrode, Depth
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.
FDA root cause: Component change control
Action: FHC issued Urgent Medical Device Recall letter dated 6/17/20 via USPS certified return receipt,stating reason for recall, health risk and action to take: FHC, Inc. field representatives will be contacting you to return the effected product and issue a replacement. In the interim, we advise you to stop use of this product. Should you have any further questions regarding this matter you may contact me, by email at [email protected] or by telephone at 207-666-5425.
Quantity in commerce: 6 units
Distribution: US Nationwide distribution including in the states of CA, NC, TN, TX, WA.
Product codes and lots: Serial Numbers: 45695, 48871, 48873, 48874, 46195, 46198

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2540-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2540-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-08

Product code GZL

K183123Class IImicroTargeting Guideline 4000 5.0 SystemFHC, Inc. / cleared 2018-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)