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.
FDA Recall Z-0495-2013 · Posted 2012-12-10
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Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeMHX
Date Initiated2012-11-09
Product Quantity3165
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.
Firm Action
Philips sent an URGENT - Medical Device Correction letter dated November 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Philips is conducting a voluntary correction to replace the audio cable on affected devices. Customer were instructed to follow the "Action to be taken by CustomerUser" section of the instructions. Customers with wquestions were instructed to contact their Phililps representataive or contact the Customer Care Solutions Center at (800) 722-9377.
For questions regarding this recall call 978-687-1501.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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