medical Class II Updated 2019-05-22

Philips North America, LLC recalls SureSigns VS4 Government Bundle, Product Number 863286. For

Recalled Product

SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).


Hazard / Issue

System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.
View official government recall

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