Neurosign V4 Intraoperative Nerve monitor family of recall
Neurosign V4 Intraoperative Nerve monitor family of devices.
Why was Neurosign V4 Intraoperative Nerve monitor family of recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers # 001 to 049. US product serial number is 039.
- Product
- Neurosign V4 Intraoperative Nerve monitor family of devices.
- Recalling firm
- The Magstim Company Limited
- Quantity
- 49 devices
- Distribution
- 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.
- Recall date
- September 2, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)