Model note · IONM
Cadwell Cascade IOMAX Intraoperative Monitor
The Cascade IOMAX is a multimodality intraoperative neuromonitoring system built from Cadwell amplifier and stimulator modules, a standard laptop or desktop PC and Cadwell Surgical Studio software. It records evoked potentials, free run and triggered EMG, EEG, transcranial motor evoked potentials, nerve conduction and train of four, and adds SpO2 and heart rate. A remote reader lets a physician review the case live from outside the theatre.
The model
Maker, model and type.
- Maker
- Cadwell Industries, Inc.
- Model
- Cascade IOMAX Intraoperative Monitor with Surgical Studio software
- Device type
- IONM
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Modalities | SSEP, BAEP and VEP evoked potentials, TcMEP, free run and triggered EMG, EEG, nerve conduction, train of four, cortical stimulation, threshold mode, SpO2 and heart rate | Source |
| Amplifier channels | Up to 48 | Source |
| Module configuration | One Cortical Module plus up to four Limb Modules | Source |
| Stimulator output modes | High and low outputs constant current; TcMEP output constant current or constant voltage | Source |
| Cortical Module contents | 16 channel amplifier, low current stimulator, TCS stimulator, visual and auditory stimulators | Source |
| Low current stimulator range | One constant current output pair, 0.01 to 20 mA | Source |
| Transcranial (TCS) stimulator range | Nine independent outputs, 50 to 1500 mA constant current or 50 to 1000 V constant voltage | Source |
| Enclosure ingress protection tested | IEC 60529, IP67 | Source |
| Software level of concern | Moderate, developed to IEC 62304 | Source |
| FDA clearance | K162199, decided 2 March 2017, primary product code GWF, predicate Nihon Kohden Neuromaster G1 MEE-2000 | Source |
Recalls
Known FDA recalls.
- Z-0141-20272026-08-18
Defective PCBA in some Cortical Modules could deliver unintended stimulation or let current reach the patient.
FDA record - Z-2349-20242024-05-17
Defective printed circuit board could damage internal components and cause unintended stimulation.
FDA record - Z-1882-20242024-04-23
Insulator possibly fitted incorrectly, allowing arcing to patient connections.
FDA record
Safety
Safety warnings from the record.
- The TCS stimulator can deliver up to 1000 V or 1500 mA, so electrode placement and stimulus limits must follow the operator manual and the supervising clinician. Source
- A wrongly fitted insulator inside the Cortical Module can let current arc to patient connections, so modules on the recall list must not be used. Source
- The system is for use by or under the direction of a licensed physician, surgeon or neurologist in a professional healthcare facility. Source
Sources
Where this note comes from.
- Cadwell IOMAX page
- FDA 510(k) K162199 summary, Cascade IOMAX Intraoperative Monitor
- openFDA recall search, IOMAX
Not covered: Cadwell's operator and service manuals are not publicly available, so no error codes, calibration steps or part numbers are listed. MAUDE returned no records under the brand name IOMAX, so there is no failure trend. Limb Module specifications were not found in a public source.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
IONM