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U.S. Department of Health and Human Services

Class 2 Device Recall GE LOGIQ Book

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  Class 2 Device Recall GE LOGIQ Book see related information
Date Initiated by Firm September 02, 2004
Date Posted January 11, 2006
Recall Status1 Terminated 3 on January 05, 2007
Recall Number Z-0387-06
Recall Event ID 33266
510(K)Number K014206  
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935
Code Information all serial numbers
Recalling Firm/
General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
Manufacturer Reason
for Recall
The Estimated Fetal Weight (EFW) result will be incorrect if the operator fails to perform the 'end exam' or new patient registration step before starting an EFW measurement procedure on the next patient.
FDA Determined
Cause 2
Action Devices will have software upgrades done by GE Field Service Technicians. The upgrade will include a dialog box which will display on the screen when prior data exists and a new patient is being registered.
Quantity in Commerce 2698
Distribution nationwide 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 = IYN and Original Applicant = GENERAL ELECTRIC CO.