Device recall
Z-0095-2019: GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE…
FDA device recall · Class II · GE Healthcare Finland Oy
Key facts
| Recall number (Z-number) | Z-0095-2019 |
|---|---|
| Recall event | 81075 |
| Product | GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The… |
| Product code | DQK |
| Recalling firm | GE Healthcare Finland Oy |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K132533 |
| FEI number | 3002806783 |
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