Reported Jan 27, 2021 · Terminated
Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating…
The Magstim Company Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Magstim Company Limited · Spring Gardens · Whitland, N/A · N/A
Is this the product you have?
Neurosign 100Product Number 9883-01. Intraoperative
- Nerve Monitor - Product Usageindicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures
- Lot codes and dates
- Serial Numbers
250725112514251525222527253325342537
- Serial Numbers
- Amount recalled
- 7 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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