Company: Philips North America, LLC
Date of Enforcement Report: 5/22/2019
Class II:

PRODUCT

SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

Recall Number: Z-1317-2019

SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

Recall Number: Z-1318-2019

SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

Recall Number: Z-1319-2019

SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

Recall Number: Z-1320-2019

SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

Recall Number: Z-1321-2019

SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

Recall Number: Z-1322-2019

SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

Recall Number: Z-1323-2019

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

Recall Number: Z-1324-2019

REASON

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

RECALLING FIRM/MANUFACTURER

Philips North America, LLC on 4/19/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1397

DISTRIBUTION

US Nationwide and International