Recall Z-1483-2021— Welch Allyn Inc Mortara

Name: FDA recall Z-1483-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-31

Class II · Terminated

Class II FDA medical device recall by Welch Allyn Inc Mortara, initiated 2021-03-31, terminated 2024-08-16. It names one FDA 510(k) clearance: K142105. Product: 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: Devices do not meet IEC 60601-2-27 requirements as labeled..

Recalling firm: Welch Allyn Inc Mortara
Classification: Class II
Status: Terminated
Initiated: 2021-03-31
Terminated: 2024-08-16
Firm location: Milwaukee, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K142105 — ELI 380 ELECTROCARDIOGRAPHMortara Instrument, Inc.·cleared 2014-09-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.