Maquet Cardiovascular Us Sales, Llc 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

Maquet/Getinge issued Urgent Medical Device Correction letter dated August 7, 2020, issued via FedEx 2 day delivery. Letter states reason for recall, health risk and action take: Please examine your inventory immediately to determine if you have a Rotaflow System with a serial number of 94175452 or greater. The serial number tag is on the back of the device (see image below). Please contact your Getinge representative or email IFUrotaflowsystem.cp@getinge.com to request 1 (one) revised IFU/(s). Please supply a mailing address, contact person and phone number on page 4. Please complete and return the form (page 4) to acknowledge this recall by emailing a scanned copy to IFUrotaflowsystem.cp@getinge.com or by faxing the form to 18664771833. A revised IFU will be shipped to you as quickly as possible. In the mantime, please attach a copy of this letter to each copy of the affected IFU. Once you receive the revised IFU, please dispose of the old IFU with the incorrect serial number reference. Qquestions, telephone number +1 973 709 7412 or through email at Rachana.Patel@getinge.com.