EarlyVue VS30 Vitals Monitor May Fail to Alarm on Respiration Rate Violations
A software defect in the Philips EarlyVue VS30 Vitals Monitor prevents alarms when respiration rate limits are violated, potentially delaying detection of dangerous breathing changes. Thirteen devices distributed in Massachusetts, Michigan, and Brazil are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a software defect in a vital signs monitor that could prevent proper alarming during respiratory rate threshold violations. Although no injuries have been reported and the hazard is theoretical, the risk-of-harm nature of the product in clinical monitoring contexts justifies a High severity rating.
Plain-English summary
The Philips EarlyVue VS30 Vitals Monitor is a medical device designed to continuously monitor patient vital signs, including acoustic respiration rate (RRa), in clinical settings. The monitor is intended to alert clinicians when monitored values exceed or fall below operator-set high and low thresholds.
A software defect in the device prevents it from alarming when respiration rate limits are violated. This could delay detection and notification of critical respiratory changes that require immediate clinical intervention.
Thirteen units of the EarlyVue VS30 have been identified as affected by this defect. The specific serial numbers have been documented, and the devices are distributed in Massachusetts, Michigan, and Brazil. Philips North America LLC is conducting this Class II recall.
The recalled product
- Product
- EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Vitals Monitor
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00884838091412
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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