Device recall
Z-1511-2017: IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a…
FDA device recall · Class II · Ohmeda Medical
Key facts
| Recall number (Z-number) | Z-1511-2017 |
|---|---|
| Recall event | 76283 |
| Product | IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They fulfill the same purpose… |
| Product code | FMT |
| Recalling firm | Ohmeda Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2018 |
| 510(k) numbers | K963058 |
| FEI number | 1121732 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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