EarlyVue VS30 Vitals Monitor recall: Software Issue
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
Why was EarlyVue VS30 Vitals 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: 00884838091412; Serial Numbers: DE72401360 DE72401393 DE72400231 DE72400232 DE72400235 DE72400254 DE72400237 DE72400238 DE72400239 DE72409250 DE72409240 DE72409249
- Product
- EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
- 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)