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Philips Medical Systems (Cleveland) Inc recalls Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanne
Recalled July 10, 2013 · FDA recall Z-1646-2013 · Philips Medical Systems (Cleveland)
Hazard
Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images. · FDA Class II
Units
2348 total units: 2182 Brilliance CT 64 units; 95 Ingenuity Core units; and 71 Ingenuity Core128 units.
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Description
Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images.
Product
Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →