FHC Guideline 4000 5 — Class II medical device recall Z-2540-2020
Terminated recall by FHC, Inc., reported 2020-07-15, distributed nationwide. An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interfere
| Recall number | Z-2540-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | FHC, Inc., Bowdoin, ME, United States |
| Recall initiated | 2020-06-17 |
| Classified | 2020-07-08 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2020-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 6 units |
| UPC / GTIN / UDI-DI | 00873263006740 |
| Serial numbers | 45695, 46195, 46198, 48871, 48873, 48874 |
| Model numbers | C0215 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2540-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.