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Philips Medical Systems (Cleveland) Inc recalls The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produ
Recalled October 8, 2014 · FDA recall Z-2711-2014 · Philips Medical Systems (Cleveland)
Hazard
Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user. · FDA Class II
Units
79
Sold at
Worldwide Distribution - US including the states of : AZ, CA, CT, FL, GA,MA, MS,OH, PA, TX, and WY., and the countries of : Australia, Denmark, Finland, France, Germany, India, Ireland, Japan, Malaysia, Netherlands, New Zealand, Norway, Russia, Slovakia, South Africa, South Korea, Sweden, Switzerland and United Kingdom.
Description
Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.
Product
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →