Welch Allyn recalls Surveyor S12/S19 bedside monitors with specific patient cables due to potential failure in defibrillation tests. Affected units may not meet medical safety standards.
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Welch Allyn is recalling Surveyor S12 and S19 bedside monitors with certain patient cables because they might not meet safety standards for defibrillation. This could pose a risk during medical emergencies where defibrillation is needed.
The recalled products may not meet the required defibrillation withstand standards for medical electrical equipment. This means the devices could fail during critical medical emergencies where defibrillation is necessary, potentially leading to serious harm.
Healthcare providers using the Surveyor S12/S19 bedside monitors with the specified patient cables are most at risk. Patients receiving care from these devices could be affected if the monitors fail during critical medical situations.
Check for the model numbers SUR12-XXX-XXXXX, SUR19-XXX-XXXXX, 9293-033-52, or 9293-033-53 on the device. The patient cables are labeled as PAT CBL 10WIRE AHA SNAP JSCREW or PAT CBL 10WIRE IEC SNAP JSCREW.
Look for model numbers SUR12-XXX-XXXXX, SUR19-XXX-XXXXX, 9293-033-52, or 9293-033-53 on the monitor.
Reach out to Welch Allyn for guidance on whether your specific device is affected and next steps.
The recalled products may not meet the required defibrillation withstand standards for medical electrical equipment, which could lead to failure during critical medical emergencies.
Check the model numbers on your device and contact Welch Allyn for specific guidance on whether your device is affected.
The recall indicates a potential risk during defibrillation emergencies, but the exact hazard level is not specified in the notice.
We’ve drafted a message you can send Welch Allyn to request your refund or repair — edit it as you like.
Subject: Recall Z-1816-2020 — Welch Allyn Welch Allyn Hello, I own a Welch Allyn that is covered by recall Z-1816-2020 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.
