Neurosign V4 Intraoperative Nerve Monitor (2018-10-21)
- Starting date:
- October 21, 2018
- Posting date:
- November 2, 2018
- 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-68178
Affected products
Neurosign V4 Intraoperative Nerve Monitor
Reason
It has been identified during our quality processes that pre-amplifier cables may be damaged by inappropriate handling during the storage process. This may lead to (partial) loss of the electromyography (EMG) audio signal of the device; however the EMG waveform is still visible on the screen. This may also result in failure of the pre-amplifier or stimulator to be recognised by the system.
Affected products
Neurosign V4 Intraoperative Nerve Monitor
Lot or serial number
All lots.
Model or catalog number
4230-00
Companies
- Manufacturer
-
The Magstim Company Limited
Spring Gardens, Carmarthenshire
Whitland, Wales
SA34 0HR
UNITED KINGDOM