Welch Allyn recalls ELI 380 electrocardiographs with AM12M acquisition module software version 1.5.1 due to failure to meet IEC 60601-2-27 safety standards. Affected units may not be safe for medical use.
Devices do not meet IEC 60601-2-27 requirements as labeled.
Welch Allyn is recalling ELI 380 electrocardiographs with specific AM12M acquisition modules that have software version 1.5.1. This version does not meet international medical device safety standards, potentially putting users at risk of electrical hazards during medical monitoring.
The recalled software version fails to meet IEC 60601-2-27 safety standards, which are designed to prevent electrical hazards in medical devices. This could lead to improper electrical function during patient monitoring, potentially causing electrical shocks or device malfunctions.
Healthcare providers using the ELI 380 electrocardiograph with AM12M acquisition module software version 1.5.1 are most at risk. Patients using these devices for medical monitoring could face electrical safety issues.
Check for the part number ELI380-ACX32, ELI380-DAX3X, ELI380-DBX32, or ELI380-DCX32 with serial numbers listed in the recall notice. The affected software version is 1.5.1 for the AM12M acquisition module.
Verify the AM12M acquisition module software version is 1.5.1 by checking the device settings or documentation.
Reach out to Welch Allyn Inc Mortara directly for confirmation of affected units and next steps.
The recall indicates the software version does not meet international safety standards, but the risk level is low. The device may not function safely during medical monitoring.
Check if your AM12M acquisition module software is version 1.5.1 and contact Welch Allyn Inc Mortara for guidance on next steps.
Look for the part numbers ELI380-ACX32, ELI380-DAX3X, ELI380-DBX32, or ELI380-DCX32 with the specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Welch Allyn to request your refund or repair — edit it as you like.
Subject: Recall Z-1483-2021 — Welch Allyn Welch Allyn Hello, I own a Welch Allyn that is covered by recall Z-1483-2021 from Welch Allyn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
