Welch Allyn recalls H12+ Holter Recorders patient cables due to potential failure to meet defibrillation standards. Affected units may not safely withstand electrical shocks during medical use.
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 H12+ Holter Recorders because they may not meet safety standards for defibrillation. This could lead to electrical issues during medical use, potentially causing harm to patients.
The patient cables may not meet safety standards for defibrillation, meaning they could fail under electrical stress during medical procedures. This could lead to electrical shocks or equipment malfunction during critical patient care.
Healthcare providers using Welch Allyn H12+ Holter Recorders with specific patient cables are affected. Patients using these devices may be at risk if the cables fail during medical procedures.
Check for the device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, or PAT CBL 10WIRE LEADFORM XL IEC SNAP. Affected units have model numbers starting with H12PLUS-XXX-XXXXX or specific codes like 9293-017-50.
Verify the device name and model numbers listed in the recall notice to confirm if your H12+ Holter Recorder patient cable is affected.
The patient cables may not meet safety standards for defibrillation, which could lead to electrical issues during medical procedures.
The affected cables have the device names: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, or PAT CBL 10WIRE LEADFORM XL IEC SNAP.
Check the model numbers on your device, which start with H12PLUS-XXX-XXXXX or specific codes like 9293-017-50, 9293-017-51, 9293-026-50, or 9293-026-51.
We’ve drafted a message you can send Welch Allyn to request your refund or repair — edit it as you like.
Subject: Recall Z-1812-2020 — Welch Allyn Welch Allyn Hello, I own a Welch Allyn that is covered by recall Z-1812-2020 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.
