The Magstim Company Limited recalls Neurosign V4 Intraoperative Nerve monitor family of devices.

Recall date

June 23, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2884-2020

FDA classification

Class II

Brand / firm

The Magstim Company Limited

Sold / 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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Neurosign V4 Intraoperative Nerve monitor family of devices.