Device recall
Z-2184-2018: CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following…
FDA device recall · Class II · Cellavision AB
Key facts
| Recall number (Z-number) | Z-2184-2018 |
|---|---|
| Recall event | 80137 |
| Product | CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The… |
| Product code | JOY |
| Recalling firm | Cellavision AB |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K033840, K092868 |
| FEI number | 3003630693 |
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