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U.S. Department of Health and Human Services

Class 2 Device Recall CIC Pro Clinical Inforamtion Center Central Information Central Station

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  Class 2 Device Recall CIC Pro Clinical Inforamtion Center Central Information Central Station see related information
Date Initiated by Firm October 11, 2004
Date Posted October 21, 2004
Recall Status1 Terminated 3 on July 22, 2006
Recall Number Z-0030-05
Recall Event ID 30018
510(K)Number K032370  
Product Classification Detector And Alarm, Arrhythmia - Product Code DSI
Product GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6
Code Information All serial numbers for versions 3.x, 4.0.5, and 4.0.6
Recalling Firm/
Manufacturer		 General Electric Medical Systems Information Technology
8200 W Tower Ave
Milwaukee WI 53223-3219
Manufacturer Reason
for Recall		 The following two conditions may occur with the printing of full disclosure strips and reports, printing of the alarm history events stored on a GE Unity Network Patient Data Server (PDS), and printing of caliper reports in the GE CIC Pro central station monitoring product, 1) a delay or cessation in updating portions of th display screen: or, 2) System reset/restart.
FDA Determined
Cause 2		 Other
Quantity in Commerce 11,778
Distribution Distributed nationwide throughout the United States and worldwide.
Total Product Life Cycle TPLC Device Report
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 = DSI and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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