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Terminated

LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477.

FDA Recall Z-0386-06 · Posted 2006-01-11

Recalling FirmGeneral Electric Med Systems LLC
Recall StatusTerminated
Product CodeIYN
Date Initiated2004-09-02
Date Terminated2007-01-05
Product Quantity393

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.

Firm 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.

Root Cause

Other

Distribution Pattern

nationwide and worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K014097GE LOGIQ 5GE Medical Systems · 2002-01-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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