EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) si
Summary
The FDA issued a Class II for EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestrea by Philips North America Llc. Reason: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated..
Details
Source
Device Recall
External ID
Z-2655-2023
Action Date
2023-10-11
Status
Ongoing
Category
device
Product Description
EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
Lot/Code Info: UDI-DI: 00884838075900; Serial Numbers: CN82203600
Quantity Affected: 13 total devices
Reason for Recall
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Distribution
Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-31
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America Llc has 302 FDA actions in our database, including 302 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America Llc have FDA actions?
Philips North America Llc has 302 FDA actions in our database, including 302 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2655-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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