GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicat
FDA device recall Z-1640-2014 · posted 2014-05-21 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- KOI
- Quantity 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,
- Date initiated
- 2014-04-09
- Date posted
- 2014-05-21
- Date terminated
- 2015-09-28
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES (K051635) | GE Healthcare | 2005-07-15 |
| AS/3 NMT MODULE (K955026) | Datex Medical Instrumentation, Inc. | 1997-04-28 |