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U.S. Department of Health and Human Services

Class 2 Device Recall Central Station Monitor

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  Class 2 Device Recall Central Station Monitor see related information
Date Initiated by Firm January 02, 2003
Date Posted February 28, 2003
Recall Status1 Terminated 3 on February 15, 2006
Recall Number Z-0597-03
Recall Event ID 25430
510(K)Number K011093  
Product Intellivue Information Center
Model: M3150BU#CO1
Code Information 4225A00169 4225A00171 4225A00181 4225A00182 4213A13456 4131A13457 
Recalling Firm/
Manufacturer		 Philips Medical Systems, Inc. Cardiac & Monitoring Systems
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Brenda Getchell
978-659-2134
Manufacturer Reason
for Recall		 Central Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up
FDA Determined
Cause 2		 Other
Action Philips Medical Systems notified users by Certified Mail on/about 2/19/03 that the firm was initiating a device field correction (recall) to conduct an upgrade to units witha HP VL400 or VL420 computer which is cconfigured for dual display by replacing the video and network communication card. Previous to this notification, Philips sent letters on 1/2/03 addressed to Biomedical Engineering Manager to advise users to reboot the system in the event of a system freeze.
Quantity in Commerce 7 units
Distribution Nationwide Canada, Europe, Asia, Latin America
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.
510(K) Database 510(K)s with Product Code = and Original Applicant = AGILENT TECHNOLOGIES, INC.
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