Home / Recalls / Welch Allyn Inc Mortara / Z-1482-2021

Z-1482-2021 Class II Terminated

Recalled by Welch Allyn Inc Mortara — Milwaukee, WI

Recall Details

Product Type
Devices
Report Date
April 28, 2021
Initiation Date
March 31, 2021
Termination Date
August 16, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
99 units

Product Description

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.

Reason for Recall

Devices do not meet IEC 60601-2-27 requirements as labeled.

Distribution Pattern

US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.

Code Information

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, 118120622367, 118180633837, 118180633838, 118180633839, 118180633840, 118190635342, 118190635353 Part Number: ELI280-LDX-ADFBG (Device Identifier: 732094319941); S/N: 119480000195, 119480000191, 119480000193, 119480000194, 119480000192

Other recalls by Welch Allyn Inc Mortara

  • Z-0011-2022 Class II — ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR2 (September 3, 2021)
  • Z-1485-2021 Class II — AM12M Acquisition Module accessory. Impacted software version of the AM12M is v (March 31, 2021)
  • Z-1484-2021 Class II — Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessor (March 31, 2021)
  • Z-1483-2021 Class II — ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted s (March 31, 2021)