Welch Allyn recalls replaceable lead sets for Wireless Acquisition Modules due to potential failure to meet defibrillation withstand requirements in medical electrical equipment.
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Welch Allyn is recalling replaceable lead sets for Wireless Acquisition Modules (WAM) that may not meet defibrillation withstand standards. This could affect the safety of medical equipment used for electrocardiography.
The recall states that impacted products may not meet the defibrillation withstand requirements of medical electrical equipment standards. This means the lead sets could fail under electrical stress during defibrillation procedures, potentially causing equipment malfunction or injury.
Healthcare professionals using Welch Allyn's replaceable lead sets for ECG equipment are likely affected. Those with the specific model numbers listed in the recall are at risk.
Check for model numbers: 9293-046-60 to 9293-047-71, 9293-017-50 to 9293-017-51, 9293-026-50 to 9293-026-51, 9293-061-50 to 9293-061-53, and 9293-033-52 to 9293-033-53, or 9293-034-50. Products sold under specific device names like LEAD SET WAM 10 WIRE BANANA AHA GRAY are affected.
Identify the model number on your lead set to see if it matches the listed numbers in the recall.
Reach out to Welch Allyn for guidance on the recall and next steps if your product is affected.
The recall states that impacted products may not meet the defibrillation withstand requirements of medical electrical equipment standards, which could lead to equipment failure during defibrillation procedures.
Check the model number on your lead set against the listed numbers: 9293-046-60 to 9293-047-71, 9293-017-50 to 9293-017-51, 9293-026-50 to 9293-026-51, 9293-061-50 to 9293-061-53, and 9293-033-52 to 9293-033-53, or 9293-034-50.
The recall does not specify a remedy, so contact Welch Allyn for guidance on the next steps.
We’ve drafted a message you can send Welch Allyn to request your refund or repair — edit it as you like.
Subject: Recall Z-1819-2020 — Welch Allyn Welch Allyn Hello, I own a Welch Allyn that is covered by recall Z-1819-2020 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.
