EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
Reported: October 11, 2023 Initiated: August 31, 2023 #Z-2654-2023
Product Description
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
Reason for Recall
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 13 total devices
- Distribution
- Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380. Recalled by Philips North America Llc. Units affected: 13 total devices.
Why was this product recalled? ▼
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 11, 2023. Severity: Moderate. Recall number: Z-2654-2023.
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