Z-2884-2020 Class II Terminated
FDA device recall Z-2884-2020 was initiated by The Magstim Company Limited on Jun 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… The recall status is terminated (terminated Aug 16, 2024). Affected quantity: 49 devices.
Recall details
- Product Type
- Devices
- Report Date
- Sep 2, 2020
- Initiation Date
- Jun 23, 2020
- Termination Date
- Aug 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2884-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026