FDA Device recall Z-2957-2020
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that…
- FDA Device
- Class III
- terminated
- Published 2020-09-23
On 2020-09-23 the FDA classified a Class III recall of Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that… by Maquet Cardiovascular Us Sales, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2957-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-08-07 |
| Published | 2020-09-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | US |
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
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
Identifiers
| code_info | Serial Numbers: 94175452 94175453 94175454 94175455 94175460 94175461 94175462 94175515 94175516 94175517 94175518 UDI: 04037691562445 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2957-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.