Health product recall

Neurosign V4 Intraoperative Nerve Monitor (2018-12-20)

Starting date:
December 20, 2018
Posting date:
January 23, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68836

Affected products

Neurosign V4 Intraoperative Nerve Monitor

Reason

Customer reported that the device would not function - error message appeared "fatal error occurred". Investigation into the 'fatal error' system error (as shown below) has identified that two brand of SD cards are more vulnerable to this intermittent fault. It has also been confirmed that the system error is caused when insufficient time is provided when switching off the NeuroDign V4.

Affected products

Neurosign V4 Intraoperative Nerve Monitor

Lot or serial number

0037

Model or catalog number

4230-00

Companies
Manufacturer

The Magstim Company Limited

Spring Gardens, Carmarthenshire

Whitland, Wales

SA34 0HR

UNITED KINGDOM