Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2020 - (Recall #: Z-2957-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: August 7, 2020

Date Posted: September 23, 2020

Recall Number: Z-2957-2020

Event ID: 86209

Reason for Recall:

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

Status: Terminated

Product Quantity: 105 total: US: 11 each OUS: 94 each

Code Information:

Serial Numbers: 94175452 94175453 94175454 94175455 94175460 94175461 94175462 94175515 94175516 94175517 94175518 UDI: 04037691562445

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated