Neurosign 100 — Class II medical device recall Z-0869-2021
Terminated recall by The Magstim Company Limited, reported 2021-01-27, distributed in MN, NC, NY. A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configure
| Recall number | Z-0869-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Magstim Company Limited, Whitland, N/A, United Kingdom |
| Recall initiated | 2020-12-08 |
| Classified | 2021-01-15 |
| Reported by FDA | 2021-01-27 |
| Terminated | 2023-02-16 |
| Distributed | MN, NC, NY |
| Quantity | 7 units |
| Serial numbers | 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537 |
Product
Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures.
Reason for recall
A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the target Country. The specific deficiency includes: 1. Onboard voltage selector set to 240V (European Standard), versus 120V requirement for the United States and Canada. 2. Fuses installed in the Power Entry Module (PEM) 2xT315mAL (240V Standard), versus the 2xT630mAL requirement for a 120V mains supply.
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-0869-2021. 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.