Z-0869-2021Class II

Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor -

Name: Z-0869-2021 Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor -
Creator: The Magstim Company Limited
Published: 2020-12-08
License: https://open.fda.gov/license/

Magstim Inc. / initiated 2020-12-08 / Terminated / root cause: manufacturing process

FDA source

The Magstim Company Limited began a recall of Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves... on 2020-12-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0869-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-08
Posted: 2021-01-15
Terminated: 2023-02-16
Recalling firm: Magstim Inc.
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.
Product code: ETN Stimulator, Nerve
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.
Root cause tag: manufacturing process
FDA 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 [email protected] or by telephone +44 (0) 199401241111. The firm will send a service pack for the instrument.
Quantity in commerce: 7 units
Distribution: MN, NC, and NY
Product codes and lots: Serial Numbers: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0869-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0869-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-15

Product code ETN

K923056Class IINeurosign Model 100The Magstim Company , Ltd. / cleared 1992-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)