Food, drugs, devices › The Magstim Company Limited
Device recall: Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating an
FDA enforcement event 87063 is a device recall by The Magstim Company Limited of Whitland, N/A, initiated 8 Dec 2020 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 16 Feb 2023. Initiation: voluntary: firm initiated. The Magstim Company Limited has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
The Magstim Company Limited, Whitland, N/A, United Kingdom.
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…"
Distribution
"MN, NC, and NY"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0869-2021 | 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. | 7 units | Class II | Terminated | 27 Jan 2021 |
Context
Other enforcement events for The Magstim Company Limited
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Jun 2020 | Neurosign V4 Intraoperative Nerve monitor family of devices. | Device | Class II | 1 |
| 23 Mar 2020 | Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disor | Device | Class II | 2 |
| 25 Oct 2018 | HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) | Device | Class II | 1 |
| 28 Sep 2017 | Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air | Device | Class II | 1 |
All 5 events for The Magstim Company Limited
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "MN, NC, and NY"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Feb 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.