Company: GE Healthcare LLC
Date of Enforcement Report: 2/5/2014
Class lI:
PRODUCT
GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. _x000D_ _x000D_ Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Recall Number Z-0840-2014
REASON
There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient’s images and another patient’s name in the footer. This is also an issue when within Manual Film Composer, if a color image is selected for printing, another patient’s black and white image appears in the preview screen and the color image cannot be printed.
RECALLING FIRM/MANUFACTURER
GE Healthcare LLC, Waukesha , WI on 10/92013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
272 (29 US; 243 OUS)
DISTRIBUTION
Nationwide and Internationally
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