Device recall
Z-1076-2024: Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number…
FDA device recall · Class II · Maquet Medical Systems USA
Key facts
| Recall number (Z-number) | Z-1076-2024 |
|---|---|
| Recall event | 93849 |
| Product | Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine. |
| Product code | DTZ |
| Recalling firm | Maquet Medical Systems USA |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K112360 |
| FEI number | 3008355164 |
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