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.
Check against the official notice below — it lists the full affected range.
Welch Allyn/Mortara is recalling 1,009 units of the ELI 380 Electrocardiograph, a high-performance device intended for resting electrocardiograph testing. The recall was issued because the radio within the device can become disassociated with the wireless access point. The affected devices have been distributed nationwide across the United States and internationally to countries including Australia, Canada, Germany, the United Kingdom, and others.
The recall affects multiple part numbers and device identifiers of the ELI 380, as detailed in the notice. The source document does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
The radio within the device can become disassociated with the wireless access point.
Reason for recall: The radio within the device can become disassociated with the wireless access point. 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. Quantity: 1,009 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.