Device recall
Z-1149-2013: MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0)…
FDA device recall · Class II · Maquet Cardiovascular, LLC
Key facts
| Recall number (Z-number) | Z-1149-2013 |
|---|---|
| Recall event | 64641 |
| Product | MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures… |
| Product code | DTQ |
| Recalling firm | Maquet Cardiovascular, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2013 |
| 510(k) numbers | K102726 |
| FEI number | 2242352 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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