Health product recall

NEUROSIGN 100 NERVE MONITOR (2020-12-07)

Starting date:
December 7, 2020
Posting date:
December 31, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74679

Last updated: 2020-12-31

Affected Products 

NEUROSIGN 100 NERVE MONITOR

Reason

Magstim are issuing a voluntary corrective action following identification within our internal quality processes that a small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the target country. The specific deficiency includes:

  1. Onboard voltage selector set to 240v (European standard), versus 120v requirement for the United States and Canada.
  2. Fuses installed in the Power Entry Module (PEM) 2xt315mal (240v standard), versus the 2xt630mal requirement for a 120v mains supply.

Affected products

NEUROSIGN 100 NERVE MONITOR

Lot or serial number
  • 2507
  • 2511
  • 2514
  • 2515
  • 2522
  • 2527
  • 2533
  • 2534
  • 2537
Model or catalog number
  • 9883-01
Companies
Manufacturer
The Magstim Company Limited
Spring Gardens, Carmarthenshire
Whitland, Wales
SA34 0HR
UNITED KINGDOM