Philips Medical Systems: Medical Device Recall in 2016 - (Recall #: Z-0011-2017)

Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Class II

The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.

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Worldwide Distribution - US Nationwide in the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, GA, IA, IL, IN, FL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY. and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, COlumbia, Cuba, Denmark, Dijbouti, Dominican REpublic, Egypt, Estonia, Finland, France, Germany, Gilbraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Seitzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uniter Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.

Voluntary: Firm initiated