Recall Z-0869-2021
The Magstim Company Limited · initiated December 8, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Serial Numbers: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0869-2021
- Initiated
- December 8, 2020
- Terminated
- February 16, 2023
- Product code
- ETN – Stimulator, Nerve
- Quantity
- 7 units
- Distribution
- MN, NC, and NY
- Recalling firm
- The Magstim Company Limited, Whitland