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Terminated

M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip 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 is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors

FDA Recall Z-2528-2017 · Posted 2017-06-13

Recall StatusTerminated
Product CodeMHX
Date Initiated2010-12-17
Date Terminated2017-08-01
Product Quantity607 units

Reason for Recall

Potential for early component failure.

Firm Action

Philips sent an Urgent Medical Device Correction letter dated December 17, 2010, to all affected consignees. Philips will replace defective system boards in Hewlett Packard model rp5700 PCs sold with IntelliVue Information Centers to correct the problem. Philips Healthcare representatives will inspect all affected units, and any unit identified to have a defective system board will have its system board replaced at no charge to the customer. Philips is asking the following of customers in the Action to be Taken by Customer/User section of the FSN: Observe your system for any of the symptoms described in the Problem Description section above. If symptoms are noted, please contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 # 3, # 1. Do not rely exclusively on the audible alarm system for patient monitoring. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. For questions regarding this recall call 978-659-3000.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - US (Nationwide) OUS: CANADA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BELGIUM BRAZIL CHILE CHINA COLOMBIA CZECH REPUBLIC FINLAND FRANCE GERMANY GREECE INDIA INDONESIA IRELAND ITALY JAPAN KENYA KOREA, REPUBLIC OF NETHERLANDS PHILIPPINES POLAND SPAIN SWEDEN SWITZERLAND THAILAND TURKEY UNITED KINGDOM

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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