Device recall
Z-1582-2018: AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is…
FDA device recall · Class II · Radiometer Medical ApS
Key facts
| Recall number (Z-number) | Z-1582-2018 |
|---|---|
| Recall event | 79411 |
| Product | AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the… |
| Product code | CHL |
| Recalling firm | Radiometer Medical ApS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 20, 2019 |
| 510(k) numbers | K130144, K142898, K151856 |
| FEI number | 3002807968 |
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