Device recall
Z-1022-2015: VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique…
FDA device recall · Class II · INNOKAS MEDICAL OY
Key facts
| Recall number (Z-number) | Z-1022-2015 |
|---|---|
| Recall event | 70068 |
| Product | VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014. |
| Product code | MWI |
| Recalling firm | INNOKAS MEDICAL OY |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2015 |
| 510(k) numbers | K133810 |
| FEI number | 3007615597 |
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