Welch Allyn recalls ELI 10, ELI 350, and other ECG devices that may not meet safety standards for defibrillation. Consumers should contact Welch Allyn for details.
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Welch Allyn is recalling several ECG devices that may not meet safety standards for defibrillation. This could pose a risk if the device fails during use.
The devices may not meet safety standards for defibrillation, which could lead to failure during critical medical situations. This risk is specific to devices used in emergency cardiac monitoring scenarios.
Healthcare professionals and patients using Welch Allyn ECG devices may be affected. Those with medical conditions requiring regular ECG monitoring are at higher risk.
Check for model numbers like ELI10-XXX-XXXXX, ELI350-XXX-XXXXX, or R-Scribe and Connex Cardio. These devices were sold with specific serial number formats.
Reach out to Welch Allyn for specific recall information and instructions.
ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe, and Connex Cardio.
The devices may not meet safety standards for defibrillation, which could lead to failure during critical medical situations.
Contact Welch Allyn for specific instructions on how to handle the device.
We’ve drafted a message you can send Welch Allyn to request your refund or repair — edit it as you like.
Subject: Recall Z-1810-2020 — Welch Allyn Welch Allyn Hello, I own a Welch Allyn that is covered by recall Z-1810-2020 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.
