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Philips Medical Systems (Cleveland) Inc recalls IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by compute
Recalled December 14, 2016 · FDA recall Z-0705-2017 · Philips Medical Systems (Cleveland)
Hazard
A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images · FDA Class II
Units
24
Sold at
Software was distributed in the following states: AR, IN, LA, MA, MN, OR and TN. Softward was also shipped to the following countries: Belgium, Denmark, France, Germany, Japan, Korea, Switzerland and United Kingdom.
Description
A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images
Product
IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →