Company: GE Healthcare Clinical Systems
Date of Enforcement Report 6/18/2008
Class:ll
PRODUCT
GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2, Recall # Z-1155-2008
REASON
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 the usual guideline orientation. Any attempt to use the inaccurate guidelines may result in a biopsy needle puncture at the unintended location.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare Clinical Systems, Milwaukee, WI, by letter dated August 14, 2007.
Manufacturer: Wipro GE Medical Systems Ltd., Whitefield, Bangalore, India. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
61 units
DISTRIBUTION
Nationwide and Internationally
