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U.S. Department of Health and Human Services

Class 2 Device Recall Neurosign V4

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 Class 2 Device Recall Neurosign V4see related information
Date Initiated by FirmJune 23, 2020
Create DateAugust 25, 2020
Recall Status1 Terminated 3 on August 16, 2024
Recall NumberZ-2884-2020
Recall Event ID 85985
510(K)NumberK181559 
Product Classification Neurosurgical nerve locator - Product Code PDQ
ProductNeurosign V4 Intraoperative Nerve monitor family of devices.
Code Information Serial numbers # 001 to 049.  US product serial number is 039.
FEI Number 3002808356
Recalling Firm/
Manufacturer		 The Magstim Company Limited
Spring Gardens
Whitland United Kingdom
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionOn June 23 2020, the firm sent a urgent field safety notice to its costumers. What you need to do: - Identify all affected products at your facility - Raise awareness to all users of the device(s) within your organisation - If you have forwarded any affected product to other organisations, please forward them a copy of this notice, and advise us accordingly on the acknowledgement form - Complete and return the attached acknowledgement form, so we can contact you to arrange replacement of the cable. - Users should continue to routinely inspect all devices for damage or signs of wear before use, as described in the operating manual. - If damage is found or your device is exhibiting the failure modes described, contact the service department to arrange a repair or replacement. - If damage is not found and the device is behaving as expected, the device can continue to be used whilst a replacement is arranged. Care should be taken to properly store the Pre- Amplifier and Stimulator Pod using the cable storage aids provided. What happens next? The affected cables have been re-designed to improve the longevity and cable performance. Using the details provided on the acknowledgement form, we will arrange for a replacement of affected cables at your facility to the updated design. It is important to return the acknowledgement form as soon as possible so that we can arrange for your cables to be replaced. In the meantime, you can continue to use your device(s).
Quantity in Commerce49 devices
DistributionDomestic: 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = PDQ
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