The Magstim Company Limited Spring Gardens Whitland United Kingdom 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
The Magstim Company Limited Spring Gardens Whitland United Kingdom
Lot Codes / Batch Numbers
Serial Numbers: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537
Products Sold
Serial Numbers: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537
The Magstim Company Limited Spring Gardens Whitland United Kingdom is recalling Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for u due to A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains wit. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm initiated the recall by email on 12/08/2020. The letter explained the issue, requested the consignee examine the device to confirm that the voltage setting and the fuse ratings are correct.. Should there be a mismatch, the consignee is to discontinue use and notify Magstim Service Department at service@magstim.com or by telephone +44 (0) 199401241111. The firm will send a service pack for the instrument.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MN, NY, NC
Page updated: Jan 10, 2026