GE Healthcare Recalls NeuroMuscular Transmission Modules for Inaccurate Readings
GE Healthcare is recalling 1,794 NeuroMuscular Transmission Modules because they may display inaccurate muscle relaxation levels when used with ElectroSensors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device providing inaccurate physiological data, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
GE Healthcare, LLC is recalling 1,794 units of the NeuroMuscular Transmission Module (E-NMT-01). The recall affects 471 units distributed in the United States and 1,323 units distributed outside the US. The module is indicated for monitoring patient relaxation and regional block stimulation for nerve location.
The recall is due to a defect where the module, when used in conjunction with the ElectroSensor, may indicate a deeper level of muscle relaxation than the patient actually has. In clinical situations where visual hand movements are observed after Train of Four (TOF) stimulation, the patient monitor may show no counts or counts that do not correspond to the actual muscle activity.
Healthcare facilities and users should check their inventory for the affected serial numbers listed in the recall notice. If the module is found, it should be removed from service and returned to GE Healthcare for repair or replacement.
The recalled product
- Product
- GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.
- Manufacturer
- GE Healthcare, LLC
Distribution
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