CLASS II Device recall · Reported 2 Sep 2020 · FDA Enforcement Report

Neurosign V4 Intraoperative Nerve monitor family of devices recalled

The Magstim is recalling Neurosign V4 Intraoperative Nerve monitor family of devices, distributed in Minnesota. The recall was initiated on 23 Jun 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial numbers # 001 to 049. US product serial number is 039.

Quantity recalled49 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2884-2020
FDA event ID: 85985
Recalling firm: The Magstim, Whitland, N/A
Classification: Class II
Status: Terminated
Recall initiated: 23 Jun 2020
FDA classified: 25 Aug 2020
Reported: 2 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

23 Jun 2020	Recall initiated by company
25 Aug 2020	Classified by FDA	+63 days
2 Sep 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator pod, may cause damage to the internal construction of the cables.

Product as listed by the FDA

Neurosign V4 Intraoperative Nerve monitor family of devices.

Where it was distributed

Domestic: MN International: UK, Republic of Ireland, Spain, Netherlands, Canada. (Technomed Europe distributed to: Brazil, Spain, Belgium, Chile, Greece, Poland, New Zealand, Pakistan, Portugal and Thailand.

Minnesota

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from The Magstim

All 6

Reported	Class	Recall	Company	Reason	Where
27 Jan 2021Device	CLASS II	Neurosign 100, Product Number recalled by The Magstim Company	The Magstim	Other	MN, NC, NY
20 May 2020Device	CLASS II	Rapid2 PSU Stim Interconnecting Cable recalled by The Magstim Company	The Magstim	Other	Nationwide
20 May 2020Device	CLASS II	Horizon PSU Stim Interconnecting Cable recalled by The Magstim Company	The Magstim	Other	Nationwide
20 Feb 2019Device	CLASS II	Horizon Ez Arm (Part of the Horizon Tms Therapy System.) recalled	The Magstim	Other	8 states
18 Apr 2018Device	CLASS II	Rapid Therapy System consisting of: Rapid Mainframe recalled	The Magstim	Other	Nationwide

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