Reported May 28, 2014 · Terminated
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, NeuroMuscular Transmission Module
- E-NMT-01 Product UsageThe Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location
- Lot codes and dates
- Mfg Lot or Serial #
1,794 of 1,794 codes
SJC13057999HASJC13058001HASJC13058005HASJC13058006HASJC13058007HASJC13058008HASJC13058009HASJC13058010HASJC13058011HASJC13058012HASJC13058013HASJC13058014HASJC13058015HASJC13058017HASJC13058018HASJC13058020HASJC13058022HASJC13058024HASJC13058025HASJC13058028HASJC13172551HASJC13172553HASJC13172554HASJC13172555HASJC13172556HASJC13172558HASJC13172559HASJC13172562HASJC13172564HASJC13172565HASJC13172568HASJC13172620HASJC13172630HASJC13172766HASJC13172767HASJC13172769HASJC13172770HASJC13172772HASJC13172774HASJC13172775HASJC13172776HASJC13193229HASJC13193233HASJC13193234HASJC13203267HASJC13203268HASJC13203269HASJC13234522HASJC13234523HASJC13234524HASJC13234528HASJC13234529HASJC13234530HASJC13234531HASJC13234532HASJC13234533HASJC13234534HASJC13234535HASJC13234538HASJC13234540HA
- Mfg Lot or Serial #
- Amount recalled
- 1,794 (471 units US, 1,323 units OUS)
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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