Device recall
Z-0899-2017: AQURE System Software Version 2.2.0 Model #: 933-599 UDI…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-0899-2017 |
|---|---|
| Recall event | 75836 |
| Product | AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to… |
| Product code | CHL |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2017 |
| 510(k) numbers | K130144, K142898, K151856 |
| FEI number | 3010420736 |
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