ELI 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 pediatric populations.
Check against the official notice below — it lists the full affected range.
Welch Allyn Inc is recalling 99 units of the Mortara ELI 280 Electrocardiograph with AM12M Acquisition Module (software version 1.5.1) because the devices do not meet IEC 60601-2-27 requirements as labeled. The affected devices were distributed nationwide to California, Colorado, Florida, Georgia, Indiana, Louisiana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Texas, Utah, and Virginia. The recalled units include multiple part numbers with specific serial numbers identified in the recall notice.
The recall document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Devices do not meet IEC 60601-2-27 requirements as labeled.
Reason for recall: Devices do not meet IEC 60601-2-27 requirements as labeled. Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA. Quantity: 99 units Lot/code info: Part Number: ELI280-LDB-ADAAX (Device Identifier: 732094265699); S/N: 117030550918 and 117030550919 Part Number: ELI280-LDD-AAABX (Device Identifier: 732094265682); S/N: 117260576403 Part Number: ELI280-LDX-ADABX (Device Identifier: 732094265675); S/N: 118240001697 and 118150627678 Part Number: ELI280-LDX-ADFBD (Device Identifier: 732094265644); 118230000580, 118230000570, 118230000584, 118230000569, 118230000572 118230000582, 118230000574, 118230000576, 118230000577, 118230000581, 118230000568, 118230000575, 118230000583, 118230000578, 118230000571, 118230000567, 118340001621, 118340001622, 118340001623, 118400001475, 118400001471, 118400001472, 118400001476, 118400001467, 118400001470, 118400001469, 118400001482, 118400001477, 118400001481, 118400001478, 118400001479, 118400001480, 118420000070, 118420000071, 118420000065, 118420000067, 118420000068, 118420000066, 118420000069, 118430000923, 118430000946, 118430000930, 118430000932, 118430000928, 119150000011, 119150000001, 119150000002, 119150000003, 119150000010, 119150000008, 119150000009, 119150000004, 119150000007, 119180000631, 119180000632, 119180000633, 119180001155, 119180001156, 119180001153, 119180001154, 119180001157, 119260000043, 119260000442, 119260000443, 119280001568, 119270000064, 119290001054, 119290001053, 119290001048, 119290001052, 119290001050, 119290001049, 119290001051, 119290001055, 119470001878, 119470001879, 119510000132, 119510000135, 119510000134, 119510000133, 120080000860, 120050001405, 11812
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.