FDA Device recall Z-2540-2020
FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as…
- FDA Device
- Class II
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as… by Fhc, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2540-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-17 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Fhc |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers: 45695, 48871, 48873, 48874, 46195, 46198 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2540-2020%22
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