Philips Medical Systems recalls Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-secti…

Recall date

August 24, 2016

Source

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

Recall number

Z-0011-2017

FDA classification

Class II

Brand / firm

Philips Medical Systems

Sold / distributed

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, Ban…

Why it was recalled

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.

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

What was recalled

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.