Recall Z-1645-2023— Philips North America Llc
Class II · Ongoing
Class II FDA medical device recall by Philips North America Llc, initiated 2023-03-06. It names one FDA 510(k) clearance: K190624. Product: EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380. Reason: EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition..
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-06
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
Reason for recall
EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.
Data sourced from openFDA. This site is unofficial and independent of the FDA.