Recall Z-2884-2020— The Magstim Company Limited
Class II · Terminated
Class II FDA medical device recall by The Magstim Company Limited, initiated 2020-06-23, terminated 2024-08-16. It names one FDA 510(k) clearance: K181559. Product: Neurosign V4 Intraoperative Nerve monitor family of devices.. 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..
- Recalling firm
- The Magstim Company Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-23
- Terminated
- 2024-08-16
- Firm location
- Whitland, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Neurosign V4 Intraoperative Nerve monitor family of devices.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.