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

• Reason
• Affected products

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