Welch Allyn recalls Q-Stress and XScribe ECG devices due to potential failure to meet defibrillation standards. Affected models include QS-6XX-XXXXX and XSCRIBE-5XX-XXXXX series.
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Welch Allyn is recalling Q-Stress and XScribe ECG devices because they may not meet safety standards for defibrillation. This could pose a risk if the device fails during medical emergencies.
The devices may not meet safety standards for defibrillation, meaning they could fail during critical medical situations. This could lead to inadequate heart monitoring or incorrect readings in emergencies.
Healthcare professionals using these devices for heart monitoring are most at risk. Patients using the devices for diagnostic purposes may also be affected.
Check for model numbers starting with QS-6XX-XXXXX or XSCRIBE-5XX-XXXXX, XSCRIBE-6XX-XXXXX. These devices were sold for real-time ECG and heart rate monitoring.
Look for model numbers starting with QS-6XX-XXXXX or XSCRIBE-5XX-XXXXX, XSCRIBE-6XX-XXXXX.
The devices may not meet defibrillation safety standards, which could lead to inadequate heart monitoring during medical emergencies.
Check for model numbers starting with QS-6XX-XXXXX or XSCRIBE-5XX-XXXXX, XSCRIBE-6XX-XXXXX.
The recall record does not specify a remedy, so contact Welch Allyn directly for guidance.
We’ve drafted a message you can send Welch Allyn to request your refund or repair — edit it as you like.
Subject: Recall Z-1817-2020 — Welch Allyn Welch Allyn Hello, I own a Welch Allyn that is covered by recall Z-1817-2020 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.
