NEUROSIGN 100 NERVE MONITOR (2020-12-07)
- Starting date:
- December 7, 2020
- Posting date:
- December 31, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-74679
Last updated:
2020-12-31
Affected Products
NEUROSIGN 100 NERVE MONITOR
Reason
Magstim are issuing a voluntary corrective action following identification within our internal quality processes that 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:
- Onboard voltage selector set to 240v (European standard), versus 120v requirement for the United States and Canada.
- Fuses installed in the Power Entry Module (PEM) 2xt315mal (240v standard), versus the 2xt630mal requirement for a 120v mains supply.
Affected products
NEUROSIGN 100 NERVE MONITOR
Lot or serial number
- 2507
- 2511
- 2514
- 2515
- 2522
- 2527
- 2533
- 2534
- 2537
Model or catalog number
- 9883-01
Companies
- Manufacturer
-
The Magstim Company Limited
Spring Gardens, Carmarthenshire
Whitland, Wales
SA34 0HR
UNITED KINGDOM