FDA recall Z-2884-2020

Product

Neurosign V4 Intraoperative Nerve monitor family of devices.

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2020-06-23

Report date

2020-09-02

Termination date

2024-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Whitland, N/A, United Kingdom

Primary source

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