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The Magstim Company Limited recalls Neurosign V4 Intraoperative Nerve monitor family of devices.
Recalled September 2, 2020 · FDA recall Z-2884-2020 · The Magstim Company
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. · FDA Class II
Units
49 devices
Sold at
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.
Description
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
Neurosign V4 Intraoperative Nerve monitor family of devices.
Manufacturer(s)
The Magstim Company Limited
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →