Device recall
Z-2957-2020: Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage…
FDA device recall · Class III · Maquet Cardiovascular Us Sales, Llc
Key facts
| Recall number (Z-number) | Z-2957-2020 |
|---|---|
| Recall event | 86209 |
| 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 |
| Product code | KFM |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 14, 2021 |
| 510(k) numbers | K991864 |
| FEI number | 3008355164 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database