Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes..

Reason: Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.

Code information: Ingenuity Core128:System Code #728323, Serial numbers: 320001, 320016, 320076, 320077, 320080, 320085, 320086, 320087, 320088, 320089, 320091, 320113, 336001, 336002, 336003, 336006, 336007, 336008, 336009, 336010, 336014

Distribution pattern: US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX