PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 28, 2014 Initiated: April 9, 2014 #Z-1640-2014

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
1,794 (471 units US, 1,323 units OUS)
Distribution
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.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by GE Healthcare, LLC. Units affected: 1,794 (471 units US, 1,323 units OUS).
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 28, 2014. Severity: Moderate. Recall number: Z-1640-2014.

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