Philips Medical Systems (Cleveland) Inc recalls Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.

Recall date

April 29, 2016

Source

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

Recall number

Z-2380-2016

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia…

Why it was recalled

Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 products that could affect the performance of the equipment.

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 64 CT Model 728231; To produce cross-sectional images of the body.