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