EarlyVue VS30 Vital Signs Monitor Missing Calibration Alarm
Philips is recalling 1,421 EarlyVue VS30 Vital Signs Monitor units in the U.S. because a missing calibration alarm can cause inaccurate CO2 measurements and failure to detect critical patient condition changes.
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: The recall involves a risk-of-harm medical device where the defect (missing calibration alarm) could cause failure to recognize critical patient conditions. No illnesses or injuries have been reported, placing this in the High category per the rubric's criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips North America LLC is recalling EarlyVue VS30 Vital Signs Monitor units with software versions A.00.02 and A.00.01 due to a missing calibration alarm.
The recall was initiated because the missing calibration alarm creates a risk of inaccurate CO2 measurements on the monitor. This inaccuracy may result in failure to recognize important changes in a patient's vital condition.
The recall affects approximately 1,421 units distributed in the United States and 3 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 product
- Product
- EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
- Manufacturer
- Philips North America Llc
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)00884838091412 Software Version A.00.02 and A.00.01
Distribution
Distributed nationwide across the United States.
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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