Drug recall
ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting…
FDA recall event 71405 · Class II · Mortara Instrument, Inc
Key facts
| Event ID | 71405 |
|---|---|
| Recall numbers | Z-1796-2015 |
| Recalling firm | Mortara Instrument, Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | May 29, 2015 |
| Report date | Jun 24, 2015 |
| Termination date | Aug 5, 2015 |
| City | Milwaukee |
| State | WI |
| Country | United States |
| FEI number | 2183461 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: