Device recall
Z-2457-2024: Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT…
FDA device recall · Class II · Medivance Inc.
Key facts
| Recall number (Z-number) | Z-2457-2024 |
|---|---|
| Recall event | 94881 |
| Product | Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ Transmission Interface… |
| Product code | DWJ |
| Recalling firm | Medivance Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K161602, K200225 |
| FEI number | 3003329224 |
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