FDA Device recall Z-1796-2015
ELI 380 Electrocardiograph
- FDA Device
- Class II
- terminated
- Published 2015-06-24
On 2015-06-24 the FDA classified a Class II recall of ELI 380 Electrocardiograph by Mortara Instrument, citing 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 waveform….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1796-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-29 |
| Published | 2015-06-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mortara Instrument |
| Distribution | AZ, CA, FL, GA, IL, MI, NE, SC, UT, WA, WI |
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
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.
Identifiers
| code_info | Serial Number 114470237158 114470237159 114470237163 114470237169 114470237173 114470237176 114470237191 115040…Serial Number 114470237158 114470237159 114470237163 114470237169 114470237173 114470237176 114470237191 115040243225 115040243448 115040243449 115130250975 115130250976 115130250977 115130250978 115130250979 115130250980 115130250981 115130250982 115130250983 114470237160 114470237165 114470237172 114470237174 114470237178 114470237179 114470237184 114470237185 114470237188 114470237190 114470237161 114470237162 114470237168 114470237177 114470237183 114470237186 114470237187 115040243087 115140252395 115140252396 115150252749 115160253501 114470237164 114470237167 114470237171 114470237175 115040243229 115070245110 114470237166 114470237170 114470237180 114470237181 114470237182 114470237189 114370228740 115110250032 115110250033 115110250034 114110201576 114110201578 115140252393 115140252394 115140252399 115140252397 114360227784 115190256009 115190256010 115190256011 115140252400 115150252442 Serial Number 1151 |
|---|
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-1796-2015%22
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