Home / Recalls / The Magstim Company Limited / Z-2884-2020

Z-2884-2020 Class II Terminated

Recalled by The Magstim Company Limited — Whitland, N/A

Recall Details

Product Type
Devices
Report Date
September 2, 2020
Initiation Date
June 23, 2020
Termination Date
August 16, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
49 devices

Product Description

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 Pattern

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.

Code Information

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

Other recalls by The Magstim Company Limited

  • Z-0869-2021 Class II — Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Us (December 8, 2020)
  • Z-1966-2020 Class II — Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treat (March 23, 2020)
  • Z-1965-2020 Class II — Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for (March 23, 2020)
  • Z-0836-2019 Class II — HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) (October 25, 2018)
  • Z-1352-2018 Class II — Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power (September 28, 2017)