Welch Allyn recalls Surveyor S12/S19 bedside patient monitors with AM12M acquisition module software version 1.5.1 that do not meet IEC 60601-2-27 safety standards. Affected units have specific serial numbers and part numbers listed in the recall notice.
Devices do not meet IEC 60601-2-27 requirements as labeled.
Welch Allyn is recalling Surveyor S12/S19 bedside patient monitors with AM12M acquisition modules that have software version 1.5.1. The devices do not meet IEC 60601-2-27 safety standards, which could pose a risk to patient safety.
The devices do not meet IEC 60601-2-27 safety standards, which are designed to ensure medical devices operate safely. This could lead to potential malfunctions that might affect patient monitoring accuracy or safety, though the exact risk is not specified in the recall notice.
Healthcare providers using the Surveyor S12/S19 bedside patient monitors with AM12M acquisition modules and software version 1.5.1 are most at risk. The recall affects specific units with listed serial numbers and part numbers.
Check for the part numbers SUR19-FDH-XXXAX, SUR19-LDH-BXXAX, SUR19-LDH-XXXAX, SUR19-SDH-XXXAX, SUR19-TDH-XXXAX, SUR19-ZDH-XXXAX, SUR19-ZDH-XXXBX, SUR12-ADH-XXXAX, SUR12-FDH-XXXAX, SUR12-FDH-XXXBX, SUR12-LDH-BXXAX, SUR12-LDH-XXXBX, SUR12-RAG-DAABX, SUR12-RAG-EXABX, SUR12-RDF-XXXAX, SUR12-RDH-BXAAX, SUR12-RDH-XXXBX, SUR12-SDH-XXABX, SUR12-TDH-XXXBX, SUR12-UAG-XBABX, SUR12-UDH-XXXBX, and SUR12-WBE-XXXAX. The affected units have specific serial numbers listed in the recall notice.
Look for the serial numbers listed in the recall notice (e.g., 118300000441, 118300000440, etc.) on the device or its packaging.
Reach out to Welch Allyn directly to confirm if your device is affected and to get instructions on next steps.
Check if your device has the specific part numbers and serial numbers listed in the recall notice. If it matches, it is affected.
Contact Welch Allyn to confirm if your device is affected and to get instructions on next steps.
The recall notice does not mention a software update; it states the devices do not meet safety standards.
We’ve drafted a message you can send Welch Allyn to request your refund or repair — edit it as you like.
Subject: Recall Z-1484-2021 — Welch Allyn Welch Allyn Hello, I own a Welch Allyn that is covered by recall Z-1484-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
