Company: GE Healthcare, LLC
Date of Enforcement Report: 8/21/2013
Class ll:
PRODUCT
GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages. Recall Number Z-1940-2013
REASON
GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 – There was a report regarding CT number variance in time line at posterior fossa region of head perfusion. When beam hardening and helical artifacts in this region are reconstructed into the perfusion map, these artifacts will give subtle differences in the CT numbers. Event 2 – The software does not flip S DICOM coordinates when it fills in the DICOM header for tilted images using the Recon Flip/Rotate top-bottom flip (FTB). The images created are stored with an incorrect coordinate value, which incorrectly puts the image in the wrong plane causing the image coordinates annotated on a viewer to be incorrect.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 4/5/2011. Voluntary: Firm Initiated recall is complete
VOLUME OF PRODUCT IN COMMERCE
244
DISTRIBUTION
Nationwide and Internationally
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