FDA Medical Device Recalls (openFDA)
FHC, Inc.: 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
- Recall number
- Z-2540-2020
- 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
- Status
- Terminated
- Initiated
- 2020-06-17
- Posted
- not on file
- Terminated
- 2020-11-02
- 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.
- 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 kmoeykens@fh-co.com or by telephone at 207-666-5425.
- Quantity
- 6 units
- Distribution
- US Nationwide distribution including in the states of CA, NC, TN, TX, WA.
- Lot, serial or model codes
- Serial Numbers: 45695, 48871, 48873, 48874, 46195, 46198
- 510(k) numbers
- ["K183123"]
- PMA numbers
- not on file
- Product code
- GZL
- Firm FEI
- 3002250546
- Firm city
- Bowdoin
- Firm state
- ME
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28