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U.S. Department of Health and Human Services

Class 2 Device Recall Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX

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  Class 2 Device Recall Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX see related information
Date Initiated by Firm November 09, 2012
Date Posted December 10, 2012
Recall Status1 Terminated 3
Recall Number Z-0495-2013
Recall Event ID 63709
510(K)Number K102495  K081983  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product 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.
Code Information 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 
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
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.
Quantity in Commerce 3165
Distribution Worldwide Distribution - USA (nationwide) and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS
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