Z-0387-06

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

Name: Z-0387-06 LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935
Creator: General Electric Med Systems LLC
Published: 2004-09-02
License: https://open.fda.gov/license/

GE Healthcare / initiated 2004-09-02 / Terminated

FDA source

General Electric Med Systems LLC began a recall of LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935 on 2004-09-02. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0387-06
Status: Terminated
Initiated: 2004-09-02
Posted: 2006-01-11
Terminated: 2007-01-05
Recalling firm: GE Healthcare
Product: LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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 root cause: Other
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
Product codes and lots: all serial numbers

Product code IYN

K014206Class IILogiqbookGeneral Electric Co. / cleared 2002-01-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)