Z-2884-2020 Class II Terminated
FDA device recall Z-2884-2020 was initiated by The Magstim Company Limited on June 23, 2020 and is designated Class II. 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 con… The recall status is terminated (terminated August 16, 2024). Affected quantity: 49 devices.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2020
- Initiation Date
- June 23, 2020
- Termination Date
- August 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 devices
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.
Distribution Pattern
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.
Code Information
Serial numbers # 001 to 049. US product serial number is 039.