FDAFDA · Food and drugs·Recall number Z-2957-2020
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
Published September 23, 2020 · Recall initiated: August 7, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Distributor
- 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.
- Lot
- Serial Numbers: 94175452 94175453 94175454 94175455 94175460 94175461 94175462 94175515 94175516 94175517 94175518 UDI: 04037691562445
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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