Device recall
Z-1394-2023: AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE…
FDA device recall · Class II · Radiometer Medical ApS
Key facts
| Recall number (Z-number) | Z-1394-2023 |
|---|---|
| Recall event | 91917 |
| Product | AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage 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 | OUG |
| Recalling firm | Radiometer Medical ApS |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3002807968 |
At a glance
- None 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