Recall Z-0374-2016— Philips Medical Systems, Inc.

Name: FDA recall Z-0374-2016
Creator: U.S. Food and Drug Administration
Published: 2014-12-19

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-12-19, terminated 2020-09-21. It names one FDA 510(k) clearance: K102495. Product: Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.. Reason: Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification.

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Terminated: 2020-09-21
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K102495 — M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0Philips Medical Systems·cleared 2010-09-30

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 IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.

Reason for recall

Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification

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