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

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  Reason
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  Affected products

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