Recall Z-0880-2013 — Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
U.S. FDA — Device Enforcement · United States · 2012-10-24 · Class II
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Reported risk: Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project
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