The Magstim Company Limited Spring Gardens Whitland United Kingdom Neurosign V4 Intraoperative Nerve monitor family of devices. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

On 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).

Distribution

As reported by FDA

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