GE Healthcare — Class II medical device recall Z-1640-2014
Terminated recall by GE Healthcare, LLC, reported 2014-05-28, distributed nationwide. When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) v
| Recall number | Z-1640-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-04-09 |
| Classified | 2014-05-20 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2015-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BO, CA, CH, CL, CO, CR, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, IL, IN, IT, JP, KW, LT, LV, MX, MY, NL, NO, NZ, OM, PA, PL, QA, RO, SA, SE, SG, SK, TR, TW, UY, VE |
| Serial numbers | 6147434, 6343819, 6395876, 6572663, 6638349, 6665782, 6820071, 6820072, 6843531, 6843533, 6843534, 6892566, 8184633, 8184638, 8220807, 8220841, 8220842, 8220843, 8220844, 8220846, 8220847, 8220851, 8225147, 8225148, 8225149 and 475 more |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1640-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.