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U.S. Department of Health and Human Services

Enforcement Report - Week of December 19, 2012

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Product Detail

Product Description Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX 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. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. 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-0495-2013
Classification Class II
Code Info PIIC 865435 M3140 Information Center Low Acuity 865436 M3150 Information Center Local DB 865417 M3145 Information Center Small NW DB 865418 M3155 Information Center NW DB 865415 M3151 Information Center Client 865421  M3170 Patient Link 865416  M3177 Trend Display 865422  M3140 Upgrade 865423  M3150 Upgrade 865426  M3145 Upgrade 865427  M3155 Upgrade 865424  M3151 Upgrade 865266 - M3140 Information Center Low Acuity 865267  M3150 Information Center Local DB 865269  M3145 Information Center Small NW DB 865268  M3155 Information Center NW DB 865270  M3151 Information Center Client 865274  M3170 Patient Link 865271  M3177 Trend Display 865277  M3140 Upgrade 865278  M3150 Upgrade 865281  M3145 Upgrade 865282  M3155 Upgrade 865279  M3151 Upgrade PIIC iX 866023  IntelliVue Info Center iX 866117  PIIC Classic Upgrade 866027  PIIC iX HW Upgrade
Product Distributed Qty 3165
Reason For Recall Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.

Event Detail

Event Id 63709
Product Type Devices
Status Ongoing
Recalling Firm Philips Healthcare Inc.
City Andover
State MA
Country US
Voluntary / Mandated
Recall Initiation Date 2012-11-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Canada.
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