Recall Z-2957-2020— Maquet Cardiovascular Us Sales, Llc
Class III · Terminated
Class III FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2020-08-07, terminated 2021-01-14. It names one FDA 510(k) clearance: K991864. 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.
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-08-07
- Terminated
- 2021-01-14
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.