Recall Z-0824-2013— Philips Healthcare Inc.

Name: FDA recall Z-0824-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-14

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2013-01-14, terminated 2020-08-27. It names one FDA 510(k) clearance: K112652. Product: Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.. Reason: VS2+ screen may lock up and stop monitoring during patient use.

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-14
Terminated: 2020-08-27
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K112652 — SURESIGNS VS2+ -SURESIGNS VSIPhilips Medical Systems·cleared 2011-10-11

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

Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

Reason for recall

VS2+ screen may lock up and stop monitoring during patient use

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