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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-0596-03
Recall Event ID 25430
510(K)Number K011093  
Product Intellivue Information Center
Model: M3150B#C01
Code Information Serial 4225A00106 4225A00107 4225A00108 4225A00111 4225A00112 4225A00113 4225A00114 4225A00116 4225A00117 4225A00118 4225A00119 4225A00127 4225A00145 4225A00149 4225A00150 4225A00151 4225A00152 4225A00164 4225A00165 4225A00166 4225A00167 4225A00169 4225A00188 4225A00189 4213A13698 4213A13700 4225A00122 4225A00136 4225A00138 4225A00137 4225A00139 4225A00140 4225A00142 4225A00143 4225A00144 4225A00101 4225A00102 4225A00103 4225A00104 
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 39 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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