Maquet/Getinge Rotaflow System Console US — Class III medical device recall Z-2957-2020
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2020-09-23, distributed nationwide. Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applie
| Recall number | Z-2957-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2020-08-07 |
| Classified | 2020-09-11 |
| Reported by FDA | 2020-09-23 |
| Terminated | 2021-01-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, CO, ES, GB, IN, IT, KR, MX, SG, TH, TR, TW |
| UPC / GTIN / UDI-DI | 04037691562445 |
| Serial numbers | 94175452, 94175453, 94175454, 94175455, 94175460, 94175461, 94175462, 94175515, 94175516, 94175517, 94175518 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2957-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.