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Terminated

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.

FDA Recall Z-1483-2021 · Posted None

Recalling FirmWelch Allyn Inc Mortara
Recall StatusTerminated
Product CodeDPS
Date Initiated2021-03-31
Date Terminated2024-08-16
Product Quantity27 units

Reason for Recall

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

Firm Action

Recall notification letters were mailed to customers notifying them of the potential issue with recommended actions beginning April 7, 2021. The notification letter includes an acknowledgement form that must be returned to the recalling firm. Once the customer confirms the impacted units are in possession, the recalling firm will arrange for an exchange AM12M to be provided. The recalled unit will be returned to the recalling firm's service center for processing.

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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