CLASS III Device recall · Reported 23 Sep 2020 · FDA Enforcement Report
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) recalled
Maquet Cardiovascular Us Sales is recalling Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz), distributed nationwide in the US. The recall was initiated on 7 Aug 2020 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2957-2020
- FDA event ID
- 86209
- Recalling firm
- Maquet Cardiovascular Us Sales, Wayne, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Aug 2020
- FDA classified
- 11 Sep 2020
- Reported
- 23 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Aug 2020 | Recall initiated by company | |
| 11 Sep 2020 | Classified by FDA | +35 days |
| 23 Sep 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Is Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) recalled?
Yes. Maquet Cardiovascular Us Sales recalled Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) on 7 Aug 2020. The recall is Class III and its status is Terminated. Recall number Z-2957-2020.
Why was it recalled?
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
Which lots are affected?
Serial Numbers: 94175452 94175453 94175454 94175455 94175460 94175461 94175462 94175515 94175516 94175517 94175518 UDI: 04037691562445
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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