Stimulator, Electrical, Evoked Response

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System

Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.

NIM Vital Nerve Monitoring System:

Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3.

Potential for false negative response on the NIM Vital Nerve Monitoring System

Cascade IOMAX Cortical Module, REF: 190296-200

Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.

Cascade IOMAX Cortical Module, REF: 190296-200

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.

NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2

Software anomaly was identified.

NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2

Software anomaly was identified.

Nexstim eXima NBS System Software version 2.2 or higher.

Software defect: the NBS software may accidentally generate duplicate copies of one or several files.

NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1.

Software defect: the NBS software may accidentally generate duplicate copies of one or several files.

MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography.

The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow.