FDAFDA · Food and drugs·Recall number Z-1640-2014
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.
Published May 28, 2014 · Recall initiated: April 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- US Nationwide Distribution in the states of: AR, CA, CO,DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MI, MN, MO, NC, NV, NY, OH, OK, TN, TX, UT, WA, WI, WY. OUS: ARGENTINA. AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGRY, INDIA, IRA, ISRAEL, ITALY, JAPAN, KAZAKTSTAN, KUWAIT, LATVIA, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PANAMA, POLAND, QATAR, ROMANIA, RUSSIAN, F¿D¿RATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, TAIWAN, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA.
- Lot
- Mfg Lot or Serial # SJC13057999HA SJC13058001HA SJC13058005HA SJC13058006HA SJC13058007HA SJC13058008HA SJC13058009HA SJC13058010HA SJC13058011HA SJC13058012HA SJC13058013HA SJC13058014HA SJC13058015HA SJC13058017HA SJC13058018HA SJC13058020HA SJC13058022HA SJC13058024HA SJC13058025HA SJC13058028HA SJC13172551HA SJC13172553HA SJC13172554HA SJC13172555HA SJC13172556HA SJC13172558HA SJC13172559HA SJC13172562HA SJC13172564HA SJC13172565HA SJC13172568HA SJC13172620HA SJC13172630HA SJC13172766HA SJC13172767HA SJC13172769HA SJC13172770HA SJC13172772HA SJC13172774HA SJC13172775HA SJC13172776HA SJC13193229HA SJC13193233HA SJC13193234HA SJC13203267HA SJC13203268HA SJC13203269HA SJC13234522HA SJC13234523HA SJC13234524HA SJC13234528HA SJC13234529HA SJC13234530HA SJC13234531HA SJC13234532HA SJC13234533HA SJC13234534HA SJC13234535HA SJC13234538HA SJC13234540HA SJC13234541HA SJC13234542HA SJC13234543HA SJC13244575HA SJC13244581HA SJC13244583HA SJC13244584HA SJC13244588HA SJC13244589HA SJC13244590HA SJC13244592HA SJC13244593HA SJC13244594HA SJC13244665HA SJC13244666HA SJC13244668HA SJC13244669HA SJC13244670HA SJC13244672HA SJC13244674HA SJC13244675HA SJC13244677HA SJC13244678HA SJC13244679HA SJC13244680HA SJC13244681HA SJC13244682HA SJC13244929HA SJC13244930HA SJC13244931HA SJC13244932HA SJC13244938HA SJC13245120HA SJC13245121HA SJC13245122HA SJC13245123HA SJC13245124HA SJC13255139HA SJC13255140HA SJC13255141HA SJC13255142HA SJC13255143HA SJC13255144HA SJC13255145HA SJC13255146HA SJC13255147HA SJC13255148HA SJC13255320HA SJC13255322HA SJC13255324HA SJC13255328HA SJC13255329HA SJC13255350HA SJC13255351HA SJC13255353HA SJC13255355HA SJC13255358HA SJC13255359HA SJC13265506HA SJC13265508HA SJC13265509HA SJC13265555HA SJC13265556HA SJC13265557HA SJC13265558HA SJC13265562HA SJC13265570HA SJC13265571HA SJC13265572HA SJC13265573HA SJC13265574HA SJC13265575HA SJC13265576HA SJC13265577HA SJC13265578HA SJC13265580HA SJC13265582HA SJC13275790HA SJC13275791HA SJC13275792HA SJC13275793HA SJC13275794HA SJC13275795HA SJC13275796HA SJC13275797HA SJC13275804HA SJC13275805HA SJC13276097HA SJC13276098HA SJC13276099HA SJC13276101HA SJC13276102HA SJC13276104HA SJC13276106HA SJC13276109HA SJC13276110HA SJC13276111HA SJC13276112HA SJC13276113HA SJC13286329HA SJC13286333HA SJC13286334HA SJC13286335HA SJC13286340HA SJC13286341HA SJC13286401HA SJC13286407HA SJC13286410HA SJC13286609HA SJC13286615HA SJC13286616HA SJC13296973HA SJC13296974HA SJC13296978HA SJC13327704HA SJC13327705HA SJC13327706HA SJC13327710HA SJC13327711HA SJC13327712HA SJC13327941HA SJC13327942HA SJC13327943HA SJC13327944HA SJC13327945HA SJC13327946HA SJC13327947HA SJC13327948HA SJC13327949HA SJC13327950HA SJC13327951HA SJC13327952HA SJC13327953HA SJC13327954HA SJC13327955HA SJC13327956HA SJC13327957HA SJC13327958HA SJC13327959HA SJC13327960HA SJC13338115HA SJC13338116HA SJC13338117HA SJC13338118HA SJC13338119HA SJC13338120HA SJC13338121HA SJC13338122HA SJC13338123HA SJC13338124HA SJC13338125HA SJC13338126HA SJC13338127HA SJC13338128HA SJC13338129HA SJC13338130HA SJC13338131HA SJC13338132HA SJC13338133HA SJC13338137HA SJC13338138HA SJC13338139HA SJC13338140HA SJC13338141HA SJC13338142HA SJC13338143HA SJC13338144HA SJC13338145HA SJC13338146HA SJC13338148HA SJC13338149HA SJC13338150HA SJC13338151HA SJC13338152HA SJC13338154HA SJC13338155HA SJC13338156HA SJC13338158HA SJC13338159HA SJC13369172HA SJC13369180HA SJC13369288HA SJC13369289HA SJC13369302HA SJC13369304HA SJC13369305HA SJC13369308HA SJC13369309HA SJC13369311HA SJC13369312HA SJC13379525HA SJC13379526HA SJC13379527HA SJC13379528HA SJC13380324HA SJC13380335HA SJC13380336HA SJC13380340HA SJC13390823HA SJC13390824HA SJC13390825HA SJC13390826HA SJC13390827HA SJC13390828HA SJC13390829HA SJC1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.