Device recall
Z-2654-2023: EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-2654-2023 |
|---|---|
| Recall event | 93020 |
| Product | EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380 |
| Product code | DSJ |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K190624 |
| FEI number | 3016618143 |
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