Moderate FDA (Devices)·Z-0869-2021·Announced 2021-01-27

Magstim Recalls Neurosign 100 Intraoperative Nerve Monitors for Voltage Configuration Error

The Magstim Company Limited is recalling seven Neurosign 100 Intraoperative Nerve Monitors because they were configured for 240V power instead of the required 120V for the US.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a configuration error that poses a risk of electrical malfunction or damage, but the source text does not report any injuries, illnesses, or deaths.

Plain-English summary

The Magstim Company Limited is recalling seven units of the Neurosign 100 Intraoperative Nerve Monitor, Product Number 9883-01. These devices are indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve, during ENT surgical procedures.

The recall is due to a configuration error where the devices were dispatched with the onboard voltage selector set to 240V (European Standard) and equipped with 2xT315mAL fuses, rather than the required 120V setting and 2xT630mAL fuses for the United States and Canada. The affected units have serial numbers 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, and 2537.

The affected devices were distributed to facilities in Minnesota, North Carolina, and New York. Users should stop using the affected devices and contact The Magstim Company Limited for instructions on how to proceed.

The recalled product

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.
Manufacturer: The Magstim Company Limited
Category: Medical Device — Surgical Equipment
Hazard: electrical-malfunction
Affected units: 7

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

Serial Numbers: 2507
2511
2514
2515
2522
2527
2533
2534
2537

Distribution

Distributed in 3 states:

Same manufacturer · The Magstim Company Limited

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