Neurosign V4 Intraoperative Nerve Monitor (2018-12-20)
- Starting date:
- December 20, 2018
- Posting date:
- January 23, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-68836
Affected products
Neurosign V4 Intraoperative Nerve Monitor
Reason
Customer reported that the device would not function - error message appeared "fatal error occurred". Investigation into the 'fatal error' system error (as shown below) has identified that two brand of SD cards are more vulnerable to this intermittent fault. It has also been confirmed that the system error is caused when insufficient time is provided when switching off the NeuroDign V4.
Affected products
Neurosign V4 Intraoperative Nerve Monitor
Lot or serial number
0037
Model or catalog number
4230-00
Companies
- Manufacturer
-
The Magstim Company Limited
Spring Gardens, Carmarthenshire
Whitland, Wales
SA34 0HR
UNITED KINGDOM