Magstim recalls Neurosign 100 nerve monitors with incorrect voltage settings for US/Canada use. These may cause electrical issues if connected to 120V power. Affected units have specific serial numbers.
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.
Magstim is recalling certain Neurosign 100 intraoperative nerve monitors that may have been shipped without proper voltage configuration for US and Canadian power systems. This could lead to electrical problems if used with standard 120V outlets.
The device may have been set to 240V settings instead of 120V for US/Canada power systems. This could cause electrical issues when plugged into standard 120V outlets, potentially leading to malfunction or damage.
Surgical teams using the Neurosign 100 in ENT procedures in the US and Canada are most at risk. Patients undergoing facial nerve surgery may be affected if the device is used incorrectly.
Check if your Neurosign 100 has a serial number from the list: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537. The device is used during ENT surgeries to monitor facial nerves.
Verify your Neurosign 100's serial number against the list: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537.
The Neurosign 100 may have been shipped without proper voltage configuration for US and Canadian power systems, potentially causing electrical issues.
Check your serial number against the list provided. If it matches, contact Magstim for guidance.
The device may be unsafe if used with standard 120V outlets due to incorrect voltage settings. Affected units should be checked.
We’ve drafted a message you can send Magstim to request your refund or repair — edit it as you like.
Subject: Recall Z-0869-2021 — Magstim Magstim Hello, I own a Magstim that is covered by recall Z-0869-2021 from Magstim. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
