Z-0869-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2021
- Initiation Date
- December 8, 2020
- Termination Date
- February 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product Description
Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures.
Reason for Recall
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.
Distribution Pattern
MN, NC, and NY
Code Information
Serial Numbers: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537