Device recall
Z-1073-2022: 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System…
FDA device recall · Class II · Daavlin Distributing Company
Key facts
| Recall number (Z-number) | Z-1073-2022 |
|---|---|
| Recall event | 89990 |
| Product | 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5], [1 Ser CX 311-4 120-240V 50/60Hz, item # 807OS0004CX6], [1 Ser… |
| Product code | FTC |
| Recalling firm | Daavlin Distributing Company |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K100378 |
| FEI number | 1526255 |
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