Recall Z-1013-2023 ยท DPS Electrocardiograph
Baxter Healthcare Corporation
Baxter Electrocardiograph, ELI 380 -DCS21
| Date | Jan 24, 2023 (initiated Oct 31, 2022) |
| Status | Terminated |
| Reason | One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022. |
| Root cause | Process control |
| Action | The customer was contacted on 31 October 2022 to inform them of the issue and instructed not to install the device for use. |
| Quantity | 1 unit |
| Distribution | TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142105 | ELI 380 ELECTROCARDIOGRAPH Mortara Instrument, Inc., Sep 5, 2014 |