EarlyVue VS30 Vital Signs Monitor recall: Software Issue
EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code…
Why was EarlyVue VS30 Vital Signs Monitor recalled?
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00884838075900; Serial Numbers: CN82203600
- Product
- EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code…
- Recalling firm
- Philips North America Llc
- Quantity
- 13 total devices
- Distribution
- Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.
- Recall date
- October 11, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)