Recall Z-1317-2019— Philips North America, LLC

Name: FDA recall Z-1317-2019
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, Product Number 863069. 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, Product Number 863069. 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.