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Philips Electronics North America Corporation recalls M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091,
Recalled June 21, 2017 · FDA recall Z-2528-2017 · Philips Electronics North America
Hazard
Potential for early component failure. · FDA Class II
Units
607 units
Sold at
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
Description
Potential for early component failure.
Product
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
Manufacturer(s)
Philips Electronics North America Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →