Z-0869-2021 Class II Terminated
FDA device recall Z-0869-2021 was initiated by The Magstim Company Limited on Dec 8, 2020 and is designated Class II. 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… The recall status is terminated (terminated Feb 16, 2023). Affected quantity: 7 units.
Recall details
- Product Type
- Devices
- Report Date
- Jan 27, 2021
- Initiation Date
- Dec 8, 2020
- Termination Date
- Feb 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
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.
Distribution pattern
MN, NC, and NY
Code information
Serial Numbers: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0869-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026