—#156055

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

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K062271
Affected lot / code info: 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.

Why it was recalled

Potential for early component failure.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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

Timeline

Recall initiated: 2010-12-17
Posted by FDA: 2017-06-13
Terminated: 2017-08-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156055. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.