FDA Device recall 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 t…
- FDA Device
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring t… by Ge Healthcare, citing 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 actua….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1640-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-09 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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.
Reason
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
Identifiers
| code_info | Mfg Lot or Serial # SJC13057999HA SJC13058001HA SJC13058005HA SJC13058006HA SJC13058007HA SJC13058008HA SJC13058…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 SJC1 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1640-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.