The Recall Desk
HighFDA (Devices)·Z-2884-2020·Announced 2020-09-02

Magstim Recalls Neurosign V4 Intraoperative Nerve Monitors Due to Cable Damage Risk

The Magstim Company Limited is recalling 49 Neurosign V4 Intraoperative Nerve monitors because cable manipulation may damage internal construction.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a risk of harm (cable damage) without reporting specific injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The Magstim Company Limited is recalling 49 Neurosign V4 Intraoperative Nerve monitors. The recall is due to reports that manipulating the cables connecting the pre-amplifier to the nerve monitor and the stimulator pod may cause damage to the internal construction of the cables.

The affected devices have serial numbers 001 to 049, with the US product serial number being 039. The devices were distributed domestically in Minnesota and internationally to the UK, Republic of Ireland, Spain, Netherlands, and Canada. Technomed Europe distributed the devices to Brazil, Spain, Belgium, Chile, Greece, Poland, New Zealand, Pakistan, Portugal, and Thailand.

The FDA has classified this as a Class II recall. Users should contact the recalling firm for instructions on how to proceed.

The recalled product

Product
Neurosign V4 Intraoperative Nerve monitor family of devices.
Affected units
49

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 (1)

  • Serial numbers # 001 to 049. US product serial number is 039.

Distribution

Distributed in 1 state: