FDA-Device2020-09-23Class III
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
Maquet Cardiovascular Us Sales, Llc
Hazard
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
Sold states
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.
Affected count
105 total: US: 11 each OUS: 94 each
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2957-2020Don't want to check this manually?
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