| Class 2 Device Recall Philips | |
Date Initiated by Firm | December 17, 2010 |
Date Posted | June 13, 2017 |
Recall Status1 |
Terminated 3 on August 01, 2017 |
Recall Number | Z-2528-2017 |
Recall Event ID |
77437 |
510(K)Number | K062271 |
Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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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 |
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. |
Recalling Firm/ Manufacturer |
Philips Electronics North America Corporation 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact | 978-659-3000 |
Manufacturer Reason for Recall | Potential for early component failure. |
FDA Determined Cause 2 | Component design/selection |
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. |
Quantity in Commerce | 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 |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MHX
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