FDA-Device2020-09-02Class II

Neurosign V4 Intraoperative Nerve monitor family of devices.

The Magstim Company Limited
Hazard

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.

Sold states
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.
Affected count
49 devices
Manufactured in
Spring Gardens, N/A, Whitland, N/A, United Kingdom
Products
Neurosign V4 Intraoperative Nerve monitor family of devices.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2884-2020

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