ELI 380 recallZ-1483-2021 · Welch Allyn Inc Mortara · initiated Mar 31, 2021
Terminated
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 Welch Allyn Inc Mortara 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
Devices do not meet IEC 60601-2-27 requirements as labeled.
FDA root cause category: Process control
What the company is doing
Recall notification letters were mailed to customers notifying them of the potential issue with recommended actions beginning April 7, 2021. The notification letter includes an acknowledgement form that must be returned to the recalling firm. Once the customer confirms the impacted units are in possession, the recalling firm will arrange for an exchange AM12M to be provided. The recalled unit will be returned to the recalling firm's service center for processing.
Recall details
- Recall number
- Z-1483-2021
- Status
- Terminated
- Initiated by the company
- Mar 31, 2021
- Recalling firm
- Welch Allyn Inc Mortara
- Quantity
- 27 units
- Product code
- DPS
- FDA submissions
- K142105
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.
Product description
ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Code information (models, lots, serial numbers)
Part Number: ELI380-ACX32 (Device Identifier: 732094265415); S/N: 118490001284, 119150000588, 120090001355, 120090001354 Part Number: ELI380-DAX3X (Device Identifier: 812345026757); S/N: 117120557018, 117120557019, 117120557020, 117120557021, 117230571942, 117230571943, 117270577469 Part Number: ELI380-DBX32 (Device Identifier: 732094265262); S/N: 118180634420 Part Number: ELI380-DCX32 (Device Identifier: 732094265187); S/N: 118340001074, 118340001074, 118340001075, 118500001332, 118460001178, 119150000120, 119210000774, 119290000580, 119520000194, 120080001509, 120080001510, 120100000310, 120080001511, 120110002478, 120170000570
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph2 recalls0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph2 recalls0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall0 reports
- ELI 380 ELI380-DAX3XMortara Instrument, Inc. · Electrocardiograph1 recall0 reports
Product lines
Other devices under the same FDA submission
10 devices cleared under K142105 are not named by identifier in this recall. 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-DCX43Mortara Instrument, Inc. · Electrocardiograph1 recall0 reports
- ELI 380 ELI380-ACS21Mortara Instrument, Inc. · Electrocardiograph2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 87686).
- Z-1482-2021 · TerminatedELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediat…
- Z-1484-2021 · TerminatedSurveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on ad…
- Z-1485-2021 · TerminatedAM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
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 16, 2026. Text above is shown as published by the FDA.
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