Device product
Neurosign V4 Intraoperative Nerve monitor family of devices.
Z-2884-2020
Product summary
- Event
- Event 85985
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 devices
- Official record key
device-enforcement:Z-2884-2020
Official wording
Reason: Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator pod, may cause damage to the internal construction of the cables.
Code information: Serial numbers # 001 to 049. US product serial number is 039.
Distribution pattern: Domestic: MN International: UK, Republic of Ireland, Spain, Netherlands, Canada. (Technomed Europe distributed to: Brazil, Spain, Belgium, Chile, Greece, Poland, New Zealand, Pakistan, Portugal and Thailand.
Derived failure modes
-
Unknown
Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator pod, may cause damage to the internal construction of the cables.