Welch Allyn recalls T12 wireless ECG devices that may not meet international safety standards for defibrillation, requiring immediate action to prevent risks.
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Welch Allyn is recalling wireless ECG devices (T12 models) that may not meet international safety standards for defibrillation. This could pose risks if the device fails during medical emergencies.
The device may not meet safety standards for defibrillation, meaning it could fail during critical medical emergencies. This could lead to inadequate treatment if the device is needed for life-saving defibrillation.
Users of Welch Allyn T12 wireless ECG devices are affected. Healthcare professionals using these devices for patient monitoring are most at risk.
Check for model numbers T12-XXX-XXXXX or T12S-XXX-XXXXX on the device. These models incorporate wireless electrocardiographic technology for real-time ECG data.
Look for model numbers T12-XXX-XXXXX or T12S-XXX-XXXXX on the device.
The device may not meet international safety standards for defibrillation, which could lead to inadequate treatment during medical emergencies.
The recall record does not specify a remedy, so contact Welch Allyn directly for guidance.
The device may not meet safety standards for defibrillation, which could pose risks during critical medical emergencies.
We’ve drafted a message you can send Welch Allyn to request your refund or repair — edit it as you like.
Subject: Recall Z-1813-2020 — Welch Allyn Welch Allyn Hello, I own a Welch Allyn that is covered by recall Z-1813-2020 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.
