Maquet Cardiovascular Us Sales, Llc recalls Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump Syst…

Recall date

August 7, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2957-2020

FDA classification

Class III

Brand / firm

Maquet Cardiovascular Us Sales, Llc

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of ME, NY, NV, OH, TX, VA, WA and the countries of China, Colombia, India, Italy, Mexico, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United Arabic Emirates, United Kingdom.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292