Recall Z-1318-2019— Philips North America, LLC

Name: FDA recall Z-1318-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-19

Class II · Ongoing

Class II FDA medical device recall by Philips North America, LLC, initiated 2019-04-19. It names one FDA 510(k) clearance: K163649. Product: SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).. 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: Philips North America, LLC
Classification: Class II
Status: Ongoing
Initiated: 2019-04-19
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K163649 — SureSigns VS3; SureSigns VS4Philips Medical Systems·cleared 2017-03-31

K-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

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.