Device recall
Z-0447-2013: The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a…
FDA device recall · Class I · Natus Medical Incorporated
Key facts
| Recall number (Z-number) | Z-0447-2013 |
|---|---|
| Recall event | 61835 |
| Product | The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72… |
| Product code | MXM |
| Recalling firm | Natus Medical Incorporated |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 27, 2015 |
| PMA numbers | P040025 |
| FEI number | 3018859 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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