Z-1644-2023 Class II Ongoing
FDA device recall Z-1644-2023 was initiated by Philips North America Llc on March 6, 2023 and is designated Class II. 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 condi… The recall status is ongoing. Affected quantity: 64 units US; 20 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2023
- Initiation Date
- March 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64 units US; 20 units OUS
Product Description
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
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.
Distribution Pattern
Nationwide Foreign: Belgium Brazil Canada Denmark Germany Guam Hong Kong Indonesia Italy Norway Poland Singapore Sweden Switzerland United Kingdom
Code Information
UDI: (01)00884838075900 Software Version A.00.02 and A.00.01