Maquet recalls US Rotaflow System Consoles with serial numbers 94175452-94175518 due to incorrect serial number in instructions. This may cause confusion in device use.
Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the new IEC standard 60601 1 2, 4th edition
Maquet is recalling US Rotaflow System Consoles with specific serial numbers because the instructions incorrectly list a serial number. This could lead to confusion about which consoles are affected, potentially causing improper use.
The instructions for use reference an incorrect serial number (90437000) instead of the correct one (94175452). This error could cause confusion about which consoles are affected, potentially leading to improper use of the device.
Healthcare professionals using the Rotaflow System Console for blood pumping in extracorporeal circuits are most at risk if they follow incorrect instructions due to the serial number error.
Check for serial numbers 94175452 through 94175518 on the console. The device is labeled as a 115V/60Hz centrifugal pump system for blood circulation.
Look for serial numbers 94175452 to 94175518 on the console to confirm if it is affected.
The instructions for use reference an incorrect serial number (90437000) instead of the correct one (94175452).
Check the serial number on your console. If it is between 94175452 and 94175518, you may need to contact Maquet for clarification.
The recall record does not mention a remedy or fix for this specific issue.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-2957-2020 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-2957-2020 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.
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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.
