Neurosign V4 Intraoperative Nerve Monitor (2018-10-21)

Starting date:

October 21, 2018

Posting date:

November 2, 2018

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-68178

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  Reason
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  Affected products

Affected products

Neurosign V4 Intraoperative Nerve Monitor

Reason

It has been identified during our quality processes that pre-amplifier cables may be damaged by inappropriate handling during the storage process. This may lead to (partial) loss of the electromyography (EMG) audio signal of the device; however the EMG waveform is still visible on the screen. This may also result in failure of the pre-amplifier or stimulator to be recognised by the system.

Affected products