EarlyVue VS30 Vital Signs Monitor lacks calibration alarm, risking inaccurate CO2 readings
Philips EarlyVue VS30 vital signs monitors lack a calibration alarm, potentially causing inaccurate CO2 measurements. This could prevent clinicians from detecting changes in patient condition.
What this means for you
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 an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—a missing calibration alarm creates a risk of inaccurate CO2 measurement, which 'may lead to' failure to recognize patient condition changes. With no reported harms and a theoretical hazard, this fits the 'High' severity category for risk-of-harm medical devices.
Plain-English summary
Philips North America LLC is recalling EarlyVue VS30 Vital Signs Monitor units with software versions A.00.02 or A.00.01. The recall affects 64 units distributed in the United States and 20 units distributed internationally to Belgium, Brazil, Canada, Denmark, Germany, Guam, Hong Kong, Indonesia, Italy, Norway, Poland, Singapore, Sweden, Switzerland, and the United Kingdom.
The recalled monitors lack a calibration alarm function. Without this alarm, CO2 measurements may be inaccurate. Inaccurate CO2 measurements may lead to failure to recognize changes in a patient's condition.
Healthcare professionals and facility administrators using affected EarlyVue VS30 monitors with software versions A.00.02 or A.00.01 should be aware of this potential safety risk.
The recalled product
- Product
- EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
- Manufacturer
- Philips North America Llc
- Hazard
- missing-alarm
- inaccurate-measurement
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: (01)00884838075900 Software Version A.00.02 and A.00.01
Distribution
Distributed nationwide across the United States.
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