Device recall
Z-2140-2021: Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for…
FDA device recall · Class II · Maquet Medical Systems USA
Key facts
| Recall number (Z-number) | Z-2140-2021 |
|---|---|
| Recall event | 88285 |
| Product | Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled. |
| Product code | DWC |
| Recalling firm | Maquet Medical Systems USA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 3, 2022 |
| 510(k) numbers | K031544 |
| 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