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-ABS1200732094265545ELI380-ABX1200732094265514ELI380-ACQ1200732094319439ELI380-ACS1100812345026313ELI380-ACX1100812345024531ELI380-ACX1200732094265439ELI380-ACX2100812345024562ELI380-ACX2200732094265422ELI380-ACX3200732094265415ELI380-DAS4400732094265354ELI380-DBX1200732094265286ELI380-DBX2200732094265279ELI380-DCP1200732094301670ELI380-DCQ1100732094307870ELI380-DCS1100812345026917ELI380-DCS1200732094265248ELI380-DCS2100812345026924ELI380-DCS4300812345026948ELI380-DCT1200732094265217ELI380-DCX1100812345026979ELI380-DCX1200732094265200ELI380-DCX2100812345026986ELI380-DCX2200732094265194ELI380-DCX3200732094265187ELI380-DCX4300812345027006
- Part Number Device Identifier
- 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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