Welch Allyn recalls X12+ Telemeter patient cables that may not meet defibrillation safety standards. Affected units could pose a risk during medical use. 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 patient cables for their X12+ Telemeter that may not meet safety standards for defibrillation. This could pose a risk during medical procedures if the device is used improperly.
The recalled patient cables may not meet safety standards for defibrillation. This means they could fail under electrical stress during medical procedures, potentially causing harm to patients or users.
Healthcare professionals using Welch Allyn X12+ Telemeters with the specific patient cables listed are most at risk. Patients using these devices may also be affected.
Check for model numbers starting with X12PLUS-XXX-XXXXX or specific cable identifiers like PAT CBL 10WIRE LEADFORM AHA SNAP. These cables were sold with Welch Allyn X12+ Telemeters between 2020 and 2022.
Look for model numbers starting with X12PLUS-XXX-XXXXX or specific cable identifiers listed in the recall notice.
The recalled patient cables may not meet safety standards for defibrillation, which could pose a risk during medical procedures.
The recall notice does not specify a remedy or action steps for affected products.
Yes, check for model numbers starting with X12PLUS-XXX-XXXXX or specific cable identifiers like PAT CBL 10WIRE LEADFORM AHA SNAP.
We’ve drafted a message you can send Welch Allyn to request your refund or repair — edit it as you like.
Subject: Recall Z-1814-2020 — Welch Allyn Welch Allyn Hello, I own a Welch Allyn that is covered by recall Z-1814-2020 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.