Welch Allyn recalls ELI PC devices that may not meet defibrillation withstand standards for medical use. Affected models include 11066-XXX-50 and 41000-029-XX.
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Welch Allyn is recalling ELI PC devices that may not meet defibrillation withstand standards. This could pose a risk during medical emergencies if the device fails to properly handle electrical shocks.
The ELI PC device may not meet the required defibrillation withstand standards. This means it could fail to handle electrical shocks during a medical emergency, potentially causing harm to patients.
Healthcare professionals using the ELI PC device for ECG monitoring are most at risk. Patients using these devices for medical purposes could be affected if the device fails during an emergency.
Check for model numbers 11066-XXX-50 or 41000-029-XX on the device. The ELI PC device converts ECG recordings into DICOM files for medical use.
Look for model numbers 11066-XXX-50 or 41000-029-XX on the device.
The ELI PC device converts resting ECG recordings collected with WAM PC patient cables into DICOM 12-lead ECG Waveform files.
Affected models include 11066-XXX-50 and 41000-029-XX.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Welch Al:lyn to request your refund or repair — edit it as you like.
Subject: Recall Z-1811-2020 — Welch Al:lyn Welch Al:lyn Hello, I own a Welch Al:lyn that is covered by recall Z-1811-2020 from Welch Al:lyn. 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.