GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201
FDA Recall Z-1155-2008 · Posted 2008-06-12
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Recalling FirmGE Healthcare Clinical Systems
Recall StatusTerminated
Product CodeIYN
Date Initiated2007-09-04
Date Terminated2012-05-29
Product Quantity62
Reason for Recall
Inaccurate guidelines: The BE9C is an optional, small radius Bi-planar convex probe intended for use with the LOGIQ 3 Expert system in Urology application. An attempt by the user to activate the biopsy guidelines while this probe is in use will cause incorrect guidelines to be displayed on the image. The incorrect guidelines are recognized by their orientation that is left/right reversed from t
Firm Action
GE sent consignees a "GE Urgent Medical Device Correction" letter dated 8/14/07. The letter informed the customers about the problem, offer a short-term workaround and informed them that a representative will schedule a visit to upgrade the software.
Root Cause
Software change control
Distribution Pattern
Worldwide Distribution - USA (NY & AL), Korea, China, India, Brazil, Mexico, Germany, Greece, Italy, Poland, Russia, Saudi Arabia, Spain, and Czech Republic.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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