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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 Recall
GE LOGIQ Book
see related information
Date Posted January 11, 2006
Recall Status1 Open
Recall Number Z-0387-06
Recall Event ID 33266
Product LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935
Code Information all serial numbers
Recalling Firm/
Manufacturer
General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 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.
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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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