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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.

FDA Recall Z-1640-2014 · Posted 2014-05-21

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeKOI
Date Initiated2014-04-09
Date Terminated2015-09-28
Product Quantity1,794 (471 units US, 1,323 units OUS)

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

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051635DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIESGE Healthcare · 2005-07-15K955026AS/3 NMT MODULEDatex Medical Instrumentation, Inc. · 1997-04-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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