Philips Medical Systems (Cleveland) Inc recalls Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce cross-sectional images of the body by compute…

Recall date

February 5, 2015

Source

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

Recall number

Z-2258-2015

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Worldwide Distribution-US (nationwide) including the states of AR, AZ, CA, CT, DE, FL, GA, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VT, WV & WY, and to the following countries: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, Cana…

Why it was recalled

5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict

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

What was recalled

Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.