RecallDepth

LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935

This recall has been terminated (originally issued January 11, 2006).

Company
General Electric Med Systems Llc
Recall Initiated
September 2, 2004
Posted
January 11, 2006
Terminated
January 5, 2007
Recall Number
Z-0387-06
Quantity
2698
Firm Location
Waukesha, WI
Official Source
View on FDA website ↗

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.

Distribution

nationwide and worldwide

Lot / Code Info

all serial numbers

Root Cause

Other

Action Taken

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.

More recalls by General Electric Med Systems Llc

View all recalls by this company →