ELI 380 Electrocardiograph — Class II medical device recall Z-1796-2015
Terminated recall by Mortara Instrument, Inc, reported 2015-06-24, distributed in AZ, CA, FL, GA, IL, MI, NE, SC…. Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380 electroc
| Recall number | Z-1796-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mortara Instrument, Inc, Milwaukee, WI, United States |
| Recall initiated | 2015-05-29 |
| Classified | 2015-06-12 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2015-08-05 |
| Distributed | AZ, CA, FL, GA, IL, MI, NE, SC, UT, WA, WI |
| Countries outside the US | AE, AU, CA, CH, CN, DE, FI, FR, GB, IE, IN, IT, LB, MY, NL, NO, NZ, OM, PL, PT, RO, TH |
| Quantity | 176 |
| UPC / GTIN / UDI-DI | 00114470237160, 00114470237177, 00114470237184, 00114470237191, 00114490238055, 00114510240310, 00115020241385, 00115030241856, 00115030241863, 00115040243079, 00115040243086, 00115060244254, 00115060244384, 00115080245620, 00115110249772, 00115120250256, 00115150252442, 00115150252749, 00115190256011 |
| Serial numbers | 114110201576, 114110201578, 114110201950, 114110201952, 114360227772, 114360227773, 114360227784, 114370228740, 114470237158, 114470237159, 114470237160, 114470237161, 114470237162, 114470237163, 114470237164, 114470237165, 114470237166, 114470237167, 114470237168, 114470237169, 114470237170, 114470237171, 114470237172, 114470237173, 114470237174 and 151 more |
Product
ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.
Reason for recall
Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380 electrocardiograph. When used in a particular workflow, acquired ECG waveforms for one patient may become associated with the patient demographics for a different patient when the record is transmitted to a records management system.
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-1796-2015. 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.