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 comput…

Recall date

November 14, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0705-2017

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

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.

Why it was recalled

A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.