M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, ...
FDA Recall #Z-2528-2017 — Class II — December 17, 2010
Product Description
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
Reason for Recall
Potential for early component failure.
Recalling Firm
Philips Electronics North America Corporation — Andover, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
607 units
Distribution
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
Code Information
This action affects certain customers who were shipped an affected Philips Intellivue Information Center unit between June 9, 2008 and May 31, 2009. Affected products have a PC serial number range between 2UA8300XYZ and 2UA84510QW. However, only a subset of these products are affected.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated