Welch Allyn recalls Q-Tel RMS cardiac/pulmonary rehab systems due to potential defibrillation failure. Affected units may not meet medical electrical safety standards. 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 its Q-Tel RMS cardiac and pulmonary rehabilitation systems because they may not meet safety standards for defibrillation. This could pose a risk during medical emergencies if the device fails to properly handle electrical shocks.
The Q-Tel RMS system may not meet safety standards for handling electrical shocks during medical emergencies. This could lead to defibrillation failure if the device is used in critical situations requiring electrical stimulation.
Healthcare providers using the Q-Tel RMS system for cardiac and pulmonary rehabilitation are most at risk. Patients using these systems for monitoring could also be affected.
Check for the Q-Tel RMS system with model number X12PLUS-XXX-XXXXX. The product was sold by Welch Allyn Inc Mortara.
Identify the model number on your Q-Tel RMS system to confirm if it's affected.
The recall states the product may not meet safety standards for defibrillation, but the exact risk level isn't specified in the record.
Check for the model number X12PLUS-XXX-XXXXX on your Q-Tel RMS system.
The recall record does not specify a remedy, so contact Welch Allyn directly for guidance.
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-1818-2020 — Welch Al:lyn Welch Al:lyn Hello, I own a Welch Al:lyn that is covered by recall Z-1818-2020 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.
