Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer re…

Recall date

February 5, 2016

Source

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

Recall number

Z-1352-2016

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Aus…

Why it was recalled

The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.

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

What was recalled

Brilliance iCT 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