Lower riskMedical device recall · FDA · Published August 7, 2020
Maquet Rotaflow Console Recall: Incorrect Serial Number in Instructions
Maquet recalls US Rotaflow System Consoles with serial numbers 94175452-94175518 due to incorrect serial number in instructions. This may cause confusion in device use.
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
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Contact the company
📍Recalling firmMaquet Cardiovascular Us Sales, Llc45 Barbour Pond Dr · Wayne, NJ 07470-2094
“Maquet Rotaflow Console Recall: Incorrect Serial Number in Instructions.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64507-maquet-rotaflow-console-recall-incorrect-serial-number-in-instructions. Based on FDA recall #Z-2957-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2957-2020%22&limit=1).
The FDA announced on Aug. 7, 2020, that Maquet Cardiovascular Us Sales, Llc is recalling the Maquet/Getinge Rotaflow System Console US due to incorrect serial number references in the Instructions for Use. The agency issued recall number Z-2957-2020 for the Class III device.
How to tell if you have it
Brand: Maquet
Product: Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump
The Instructions for Use reference an incorrect serial number of 90437000. The document should state it applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the new IEC standard 60601 1 2, 4th edition.
Context
GovInfoNow's records show Maquet Cardiovascular Us Sales, Llc has 14 other recalls on record since 2018-10-25. Other recent recalls of similar products include the Maquet HLS Set Advanced 7.0 Recall (2020-11-20), the Maquet BMU 40 Blood Monitor Recall (2020-09-30), and the Maquet Yuno Mobile Operating Table Recall (2020-09-24).
How to tell if you have this one
Check for serial numbers 94175452 through 94175518 on the console. The device is labeled as a 115V/60Hz centrifugal pump system for blood circulation.
Brand
Maquet
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Look for serial numbers 94175452 to 94175518 on the console to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Maine, Nevada, New York, Ohio, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2957-2020 (August 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2957-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.