Device recall
Z-2295-2019: Brand Name Burn Navigator Model Numbers: Catalog 1120, Burn Navigator H2 Catalog…
FDA device recall · Class II · Arcos, Inc
Key facts
| Recall number (Z-number) | Z-2295-2019 |
|---|---|
| Recall event | 81594 |
| Product | Brand Name Burn Navigator Model Numbers: Catalog 1120, Burn Navigator H2 Catalog 1125, Burn Navigator H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523 |
| Product code | PDT |
| Recalling firm | Arcos, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 9, 2022 |
| 510(k) numbers | K121659 |
| FEI number | 3010283477 |
At a glance
- 1–9 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