Baxter Electrocardiograph, ELI 380 -DCS21 recallZ-1013-2023 · Baxter Healthcare Corporation · initiated Oct 31, 2022
Class II Terminated All recalls posted in January 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
FDA root cause category: Process control
What the company is doing
The customer was contacted on 31 October 2022 to inform them of the issue and instructed not to install the device for use.
Recall details
- Recall number
- Z-1013-2023
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 31, 2022
- Posted by the FDA
- Jan 24, 2023
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 1 unit
- Product code
- DPS
- FDA submissions
- K142105
- Distribution
- TX
Product description
Baxter Electrocardiograph, ELI 380 -DCS21
Code information (models, lots, serial numbers)
Lot number 122420001706
Other devices under the same FDA submission
11 devices cleared under K142105 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ELI 380 ELI380-DCS11Mortara Instrument, Inc. · Electrocardiograph1 recall1 death70 reports
- ELI 380 ELI380-DCX11Mortara Instrument, Inc. · Electrocardiograph1 recall12 reports
- ELI 380 ELI380-ACX11Mortara Instrument, Inc. · Electrocardiograph1 recall8 reports
- ELI 380 ELI380-DCX21Mortara Instrument, Inc. · Electrocardiograph1 recall6 reports
- ELI 380 ELI380-DCS21Mortara Instrument, Inc. · Electrocardiograph1 recall5 reports
- ELI 380 ELI380-ACX21Mortara Instrument, Inc. · Electrocardiograph1 recall3 reports
- ELI 380 ELI380-ACS11Mortara Instrument, Inc. · Electrocardiograph1 recall2 reports
- ELI 380 ELI380-DCS43Mortara Instrument, Inc. · Electrocardiograph1 recall1 report
- ELI 380 ELI380-DAX3XMortara Instrument, Inc. · Electrocardiograph1 recall0 reports
- ELI 380 ELI380-DCX43Mortara Instrument, Inc. · Electrocardiograph1 recall0 reports
- ELI 380 ELI380-ACS21Mortara Instrument, Inc. · Electrocardiograph2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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