Company: Welch Allyn Inc Mortara
Date of Enforcement Report: 4/28/2021
Class II
PRODUCT
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.
Recall Number: Z-1482-2021
REASON
Devices do not meet IEC 60601-2-27 requirements as labeled.
RECALLING FIRM/MANUFACTURER
Welch Allyn Inc Mortara on 3/31/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
99 units
DISTRIBUTION
U.S. Nationwide