Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-05-17 | Z-2349-2024 | Class II | Open, Classified | Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.Distribution: US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom | 26 units | code info di |
| 2024-04-23 | Z-1882-2024 | Class II | Open, Classified | There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.Distribution: Worldwide - US Nationwide distribution in the state of MD and the countries of Mexico, Canada, Malaysia, India, Taiwan, Saudi Arabia, European Union, Switzerland, South Africa, Iraq, United Kingdom. | 54 units | code info di |
Regulatory clearances
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-08-16 | VAI | Voluntary action indicated | Cadwell Industries Inc | 3 |
| 2017-08-16 | VAI | Voluntary action indicated | Cadwell Industries Inc | 3 |
| 2013-04-30 | VAI | Voluntary action indicated | Cadwell Industries Inc | 3 |
| 2013-04-30 | VAI | Voluntary action indicated | Cadwell Industries Inc | 3 |
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