Device recall
Z-0210-2015: Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel…
FDA device recall · Class II · Fisher & Paykel Healthcare, Ltd.
Key facts
| Recall number (Z-number) | Z-0210-2015 |
|---|---|
| Recall event | 69668 |
| Product | Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric intensive care units… |
| Product code | FMT |
| Recalling firm | Fisher & Paykel Healthcare, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2015 |
| 510(k) numbers | K970432, K971461 |
| FEI number | 3002806988 |
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