FDA Medical Device Recalls (openFDA)
The Magstim Company Limited: 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 number
- Z-0869-2021
- Recalling firm
- The Magstim Company Limited
- 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.
- Status
- Terminated
- Initiated
- 2020-12-08
- Posted
- not on file
- Terminated
- 2023-02-16
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 7 units
- Distribution
- MN, NC, and NY
- Lot, serial or model codes
- Serial Numbers: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537
- 510(k) numbers
- ["K923056"]
- PMA numbers
- not on file
- Product code
- ETN
- Firm FEI
- 3002808356
- Firm city
- Whitland
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28