Device recall
Z-0957-2024: GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c)…
FDA device recall · Class I · Wipro GE Healthcare Private Ltd.
Key facts
| Recall number (Z-number) | Z-0957-2024 |
|---|---|
| Recall event | 93780 |
| Product | GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000 |
| Product code | FMZ |
| Recalling firm | Wipro GE Healthcare Private Ltd. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K871399, K901585, K914487, K943360, K962806, K974349 |
| FEI number | 3007734888 |
At a glance
- 1–9 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