Reported Dec 16, 2020 · Terminated

ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph.…

Welch Allyn, Inc/mortara

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: WELCH ALLYN, INC/MORTARA · 7865 N 86th St · Milwaukee, WI · 53224-3431

Is this the product you have?

  • ELI 380
  • Electrocardiograph - Product Usageintended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead
Lot codes and dates
  • Part Number Device Identifier
    • ELI380-ABS12
    • 00732094265545
    • ELI380-ABX12
    • 00732094265514
    • ELI380-ACQ12
    • 00732094319439
    • ELI380-ACS11
    • 00812345026313
    • ELI380-ACX11
    • 00812345024531
    • ELI380-ACX12
    • 00732094265439
    • ELI380-ACX21
    • 00812345024562
    • ELI380-ACX22
    • 00732094265422
    • ELI380-ACX32
    • 00732094265415
    • ELI380-DAS44
    • 00732094265354
    • ELI380-DBX12
    • 00732094265286
    • ELI380-DBX22
    • 00732094265279
    • ELI380-DCP12
    • 00732094301670
    • ELI380-DCQ11
    • 00732094307870
    • ELI380-DCS11
    • 00812345026917
    • ELI380-DCS12
    • 00732094265248
    • ELI380-DCS21
    • 00812345026924
    • ELI380-DCS43
    • 00812345026948
    • ELI380-DCT12
    • 00732094265217
    • ELI380-DCX11
    • 00812345026979
    • ELI380-DCX12
    • 00732094265200
    • ELI380-DCX21
    • 00812345026986
    • ELI380-DCX22
    • 00732094265194
    • ELI380-DCX32
    • 00732094265187
    • ELI380-DCX43
    • 00812345027006
Amount recalled
1,009 units

Where it was sold

Why it was recalled

The radio within the device can become disassociated with the wireless access point.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 8, 2023 · Data as of Sep 19, 5:43 PM UTC

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