# FDA recall Z-2957-2020

> **Maquet Cardiovascular Us Sales, Llc** · Class III · device recall initiated 2020-08-07.

## 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

## 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

## 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.

## Key facts

- **Recall number:** Z-2957-2020
- **Recalling firm:** Maquet Cardiovascular Us Sales, Llc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-07
- **Report date:** 2020-09-23
- **Termination date:** 2021-01-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2957-2020

## Citation

> AI Analytics. FDA recall Z-2957-2020. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-2957-2020. Source: US FDA. Licensed CC0.

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