Z-2957-2020Class III

Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) -

Name: Z-2957-2020 Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) -
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2020-08-07
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2020-08-07 / Terminated / root cause: labeling and UDI

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of 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... on 2020-08-07. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2957-2020
Classification: Class III
Status: Terminated
Initiated: 2020-08-07
Posted: 2020-09-12
Terminated: 2021-01-14
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: 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 code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
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
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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 [email protected] 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 [email protected] 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 [email protected].
Quantity in commerce: 105 total: US: 11 each OUS: 94 each
Distribution: 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.
Product codes and lots: Serial Numbers: 94175452 94175453 94175454 94175455 94175460 94175461 94175462 94175515 94175516 94175517 94175518 UDI: 04037691562445

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2957-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2957-2020	Class III	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-11

Product code KFM

K991864Class IIRotaflow Centrifugal Pump SystemJostra Medizintechnik AG / cleared 2000-08-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)