Home / Recalls / Welch Allyn Inc Mortara / Z-1483-2021

Z-1483-2021 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
27 units

Product Description

ELI 380 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: ELI380-ACX32 (Device Identifier: 732094265415); S/N: 118490001284, 119150000588, 120090001355, 120090001354 Part Number: ELI380-DAX3X (Device Identifier: 812345026757); S/N: 117120557018, 117120557019, 117120557020, 117120557021, 117230571942, 117230571943, 117270577469 Part Number: ELI380-DBX32 (Device Identifier: 732094265262); S/N: 118180634420 Part Number: ELI380-DCX32 (Device Identifier: 732094265187); S/N: 118340001074, 118340001074, 118340001075, 118500001332, 118460001178, 119150000120, 119210000774, 119290000580, 119520000194, 120080001509, 120080001510, 120100000310, 120080001511, 120110002478, 120170000570

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-1482-2021 Class II — ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted s (March 31, 2021)