Recall Z-2303-2012— Philips Healthcare Inc.

Name: FDA recall Z-2303-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-15

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-08-15, terminated 2014-03-13. It names one FDA 510(k) clearance: K112652. Product: Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. 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. The SureSigns VSi vital signs monitor is for measurement 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: Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount.

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-08-15
Terminated: 2014-03-13
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 SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. 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. The SureSigns VSi vital signs monitor is for measurement 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

Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount

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