Philips Medical Systems (Cleveland) Inc recalls Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to pro…

Recall date

December 8, 2014

Source

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

Recall number

Z-0979-2015

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

US Nationwide Distribution - AR, AZ, CA, CO, FL, FL, GA, IL, IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, OR, PA, PA, SC, TN, TX, VA, and WA. The affected product was also distributed to one government consignee. The affected product was also distributed to the following foreign countries: Canada, Alban…

Why it was recalled

Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.

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

What was recalled

Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: 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.