Company: Philips Medical System12/1610/28
Class lI:
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. Recall Number Z-0374-2016
REASON
Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Andover, MA on 12/19/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
10,013 units
DISTRIBUTION
Worldwide
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