Recall Z-2884-2020 ยท PDQ Neurosurgical Nerve Locator
The Magstim Company Limited
Neurosign V4 Intraoperative Nerve monitor family of devices.
| Date | Jun 23, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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, |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181559 | Neurosign V4 Intraoperative Nerve Monitor Magstim Company, Ltd., Nov 9, 2018 |