Welch Allyn recalls AM12M Acquisition Module accessories with software version 1.5.1 that do not meet IEC 60601-2-27 safety standards for medical devices.
Devices do not meet IEC 60601-2-27 requirements as labeled.
Welch Allyn is recalling AM12M Acquisition Module accessories with software version 1.5.1 because they fail to meet IEC 60601-2-27 safety standards. This could pose risks during medical use, though the specific hazard isn't detailed in the recall notice.
The recall states the devices do not meet IEC 60601-2-27 requirements as labeled. This means the software version 1.5.1 may not have proper safety features for medical use, but the specific hazard mechanism isn't described in the notice.
Users of Welch Allyn AM12M Acquisition Module accessories with software version 1.5.1 are affected. Healthcare professionals using these devices for patient monitoring may be at risk.
Check for the part numbers 41000-037-50, 41000-037-51, or 9293-065-50 with serial numbers listed in the recall notice. The software version 1.5.1 is also impacted.
Verify your device's software version; if it's 1.5.1, it's affected.
The recall states the devices do not meet IEC 60601-2-27 requirements as labeled, but the specific hazard mechanism isn't described in the notice.
Check for part numbers 41000-037-50, 41000-037-51, or 9293-065-50 with serial numbers listed in the recall notice.
The recall does not specify a remedy, so no action is required beyond checking if your device is affected.
We’ve drafted a message you can send Welch Allyn to request your refund or repair — edit it as you like.
Subject: Recall Z-1485-2021 — Welch Allyn Welch Allyn Hello, I own a Welch Allyn that is covered by recall Z-1485-2021 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.
