Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 27, 2021
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.
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 s…
The Magstim Company Limited recalled Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indi… - a moderate-severity action.
Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indi… was recalled by The Magstim Company Limited in January 27, 2021. Reason: A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configur…. Check the official notice for the remedy. Verify recall #Z-0869-2021 with the FDA Devices before acting.
The recall
The Magstim Company Limited issued this moderate-severity FDA Devices recall-A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configur….
- Moderate
- severity level
- 7 units
- affected scope
- Class II
- classification
- January 27, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0869-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0869-2021) was formally reported on January 27, 2021, with the manufacturer initiating the action on December 8, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. The Magstim Company Limited is listed as the recalling firm, operating out of Whitland, N/A. Federal records list the affected scope as 7 units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: MN, NC, and NY. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
7 units
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0869-2021 |
| Date reported | January 27, 2021 |
| Date initiated | December 8, 2020 |
| Recalling firm | The Magstim Company Limited |
| Firm location | Whitland, N/A |
| Affected scope | 7 units |
| Distribution | MN, NC, and NY |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0869-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by The Magstim Company Limited. Units affected: 7 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 27, 2021. Severity: Moderate. Recall number: Z-0869-2021.
Where was the recalled product distributed? ▼
Distribution: MN, NC, and NY.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0869-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 27, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.