EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultan
Summary
The FDA issued a Class II for EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO 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-2654-2023
Action Date
2023-10-11
Status
Ongoing
Category
device
Product Description
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
Lot/Code Info: UDI-DI: 00884838091412; Serial Numbers: DE72401360 DE72401393 DE72400231 DE72400232 DE72400235 DE72400254 DE72400237 DE72400238 DE72400239 DE72409250 DE72409240 DE72409249
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-2654-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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