KOIClass II

Stimulator, Nerve, Peripheral, Electric

Anesthesiology · 21 CFR 868.2775

MDR events48All time

Recalls1All time

Registered firms126Currently listed

510(k) clearances29All time

Recent MDR events

48 adverse event reports on file

NMT CABLEApr 13, 2026
InjuryPhilips Medizin Systeme Böblingen Gmbh9610816-2026-100691
BLINK TWITCHVIEW TRAIN OF FOUR MONITORDec 1, 2025
MalfunctionBlink Device CompanyMW5179651
NMT CABLENov 21, 2025
InjuryPhilips Medizin Systeme Böblingen Gmbh9610816-2025-001103
SMART CABLE NMT MODULE AND ACCESSORIESNov 19, 2025
MalfunctionNihon Kohden Corporation23595602
NMT CABLENov 17, 2025
InjuryPhilips Medizin Systeme Böblingen Gmbh9610816-2025-001072
SMART CABLE NMT MODULE AND ACCESSORIESNov 13, 2025
MalfunctionNihon Kohden Corporation8030229-2025-05777
INTELLIVUE NMT HAND-ADAPTERNov 22, 2024
InjuryPhilips Medizin Systeme Böblingen Gmbh9610816-2024-000895
AF-201PAMar 6, 2024
MalfunctionNihon Kohden Corporation8030229-2024-04187
E-NMT MODULEAug 24, 2023
InjuryGe Healthcare Finland Oy9610105-2023-00007
TWITCHVIEWAug 1, 2022
InjuryBlink Device CompanyMW5111221

Event type breakdown

Malfunction31

Injury13

Other3

Unspecified1

Most-reported manufacturers

Organon Ireland Limited10 Ge Healthcare Finland Oy9 Philips Medizin Systeme Böblingen Gmbh4 Blink Device Company3 Nihon Kohden Corporation3 Unspecified2 Ge Healthcare2 I-flow, Llc2

Recalls

1 recall events for this product code

GE Healthcare, LLC
TerminatedMay 21, 2014
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01
When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of muscle relaxation than the actual level of muscle relaxation. In the clinical situation visual movements of the hand are seen after TOF (Train of Four) stimulation, but the patient monitor shows no counts, or counts are not corresponding to the actual a
Z-1640-2014 · View FDA record ↗

Registered firms

126 firms currently registered for this product code

510(k) clearances

29 clearances for this product code