Maquet recalls BMU 40 blood monitoring units with model 701040852 due to insufficient PCB creepage distance (1.8mm vs required 4mm), potentially causing electrical issues during cardiac surgery.
The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed circuit board (PCB) where as the standard requires a creepage distance of 4 mm.
Maquet is recalling blood monitoring units (BMU 40) with model number 701040852 because their printed circuit board has a dangerously short electrical gap (1.8mm instead of 4mm required). This could cause electrical faults during critical cardiac surgery procedures, putting patients at risk of injury.
The printed circuit board has a shorter electrical gap (1.8mm) than the required 4mm standard. This can cause electrical arcing or short circuits during high-voltage operations, potentially leading to equipment failure during critical cardiac surgery.
Healthcare professionals using the BMU 40 blood monitoring units during cardiac surgery procedures are most at risk. Patients undergoing extracorporeal circulation procedures with this device could be affected.
Check for the model number 701040852 on the BMU 40 blood monitoring unit. The units were sold with serial numbers starting from 90002022 through 90002313.
Identify the serial number on your BMU 40 unit to confirm if it's in the affected range (90002022 to 90002313).
Reach out to Maquet Cardiovascular US Sales, LLC for further instructions on how to address the issue.
The printed circuit board has a shorter electrical gap (1.8mm) than the required 4mm standard, which could cause electrical arcing during high-voltage operations in cardiac surgery.
The affected model number is 701040852 for the BMU 40 blood monitoring units.
Check the serial number on your unit; affected units have serial numbers from 90002022 to 90002313.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0443-2021 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0443-2021 from Maquet. 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.
