FDA-Device2015-08-05Class II
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.
Philips Medical Systems (Cleveland) Inc
Hazard
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
Sold states
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, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Italy, Japan, Latvia, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Panama, Philippines, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
Affected count
139 units
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2258-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief