Drug recall
EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo…
FDA recall event 93020 · Class II · Philips North America Llc
Key facts
| Event ID | 93020 |
|---|---|
| Recall numbers | Z-2654-2023, Z-2655-2023 |
| Recalling firm | Philips North America Llc |
| Product type | Devices |
| Products | EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359, EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated. |
| Initiation date | Aug 31, 2023 |
| Report date | Oct 11, 2023 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3016618143 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: