Reported Aug 21, 2013 · Terminated
GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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.
- Lot codes and dates
- GSI Viewer on CT750HD CT Systems Software Update to 10MW25.6 Serial#
244 of 244 codes
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
- GSI Viewer on CT750HD CT Systems Software Update to 10MW25.6 Serial#
- Amount recalled
- 244
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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 no
This product could cause temporary or reversible health problems — stop using it.
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