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U.S. Department of Health and Human Services

Class 2 Device Recall NeuroMuscular Transmission Module, ENMT

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 Class 2 Device Recall NeuroMuscular Transmission Module, ENMT see related information
Date Posted May 21, 2014
Recall Status1 Terminated on September 28, 2015
Recall Number Z-1640-2014
Recall Event ID 67620
510(K)Number K051635  K955026 
Product Classification Stimulator, nerve, peripheral, electric - Product Code KOI
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.
Code Information 3390830HA
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
For Additional Information Contact TECHNICAL SUPPORT
262-513-4122
Manufacturer 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
FDA Determined
Cause 2
Software design
Action GE Healthcare sent an "Urgent Medical Device Correction" letter (Ref 36099) dated April 9, 2014 to affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information (contact Technical Support at 1-800-558-7044 or your local Service Representative). UPDATE: On May 11, 2015 a second GE Healthcare letter FMI 36099-2 was sent to OUS consignees. The updated report was for additional affected modules due to FRU installation.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KOI and Original Applicant = DATEX MEDICAL INSTRUMENTATION, INC.
510(K)s with Product Code = KOI and Original Applicant = GE HEALTHCARE
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