ELI 380 recallZ-0553-2021 · Welch Allyn, Inc/Mortara · initiated Nov 11, 2020
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
The radio within the device can become disassociated with the wireless access point.
FDA root cause category: Software design
What the company is doing
The products associated with this Urgent Medical Device Correction letter were manufactured between June 03, 2019 and July 27, 2020. A list of the affected part numbers is provided in Table 1. Action to be taken by the user: o If an ECG test is needed when there is no wireless connection, follow the user manual and acquire an ECG using the STAT ECG mode. The operating software installed on the ELI380 Resting Electrocardiograph requires to be upgraded to version 2.4.3 in order to address this issue. Included with this Urgent Medical Device Correction letter is a USB flash drive with the update software to be used to update your affected units identified in Appendix C. o Enclosed in Appendix C is a list of impacted devices and serial numbers. Locate the devices in your possession and upgrade the software as soon as possible following the instructions in Appendix B or using the instructions provided on the USB flash drive. After the software is successfully upgraded, complete the enclosed Urgent Medical Device Correction Confirmation Form in Appendix C. Sign and return the form to [email protected]. Note: Instructions are provided in Appendix A to locate the serial number on the device if needed. o If technical assistance is needed during the installation process, please contact the appropriate regional technical support via phone or email using the contact information provided in the Contact Reference Person table below. o This notice should be sent to all members of your organization who need to be aware and/or to any organization where the potentially affected devices have been transferred. Transmission of this Urgent Medical Device Correction Letter: Please transfer this notice to other organization as appropriate. Please maintain awareness of this notice for an appropriate period to ensure effectiveness. Please note that this Urgent Medical Device Correction Notice is being made with the knowledge of the Food and Drug Administration (FDA). Adverse re
Recall details
- Recall number
- Z-0553-2021
- Status
- Terminated
- Initiated by the company
- Nov 11, 2020
- Recalling firm
- Welch Allyn, Inc/Mortara
- Quantity
- 1,009 units
- Product code
- DPS
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IN, KS, KY, MA, MD, MI, MO, MT, NC, ND, NH, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA, WI, WV, WY and the countries of Australia, Canada, Czech, Finland, GB, Germany, Italy, Kuwait, Netherlands, New Zealand, Norway, Qatar, Switzerland, United Arab Emirates, United Kingdom.
Product description
ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
25 devices in the FDA device registry whose identifier appears in the recall's code information.
- ELI 380 ELI380-DCS11Mortara Instrument, Inc. · Electrocardiograph1 recall1 death70 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph2 recalls0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph2 recalls0 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
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall2 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall2 reports
- ELI 380 ELI380-ACS11Mortara Instrument, Inc. · Electrocardiograph1 recall2 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall1 report
- ELI 380 ELI380-DCS43Mortara Instrument, Inc. · Electrocardiograph1 recall1 report
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph1 recall0 reports
- ELI 380 ELI380-DCX43Mortara Instrument, Inc. · Electrocardiograph1 recall0 reports
Product lines
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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