{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "121747", "product_res_number": "Z-0067-2014", "event_date_initiated": "2013-08-16", "event_date_posted": "2013-10-25", "recall_status": "Terminated", "event_date_terminated": "2014-03-26", "res_event_number": "66205", "product_code": "KPS", "k_numbers": [ "K052640" ], "product_description": "Ingenuity TF PET/CT\r\n\r\nDiagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other Oran imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a \"fused\" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders The detection, localization, and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for quantification of cardiology images and data sets including but not limited to myocardial perfusion for the display of wall motion and quantification ventricular or left-function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated.", "code_info": "Model # 882456; Serial Number: 2003 -2013 and 2015 - 2019.", "firm_fei_number": "1525965", "recalling_firm": "Philips Medical Systems (Cleveland) Inc", "address_1": "595 Miner Rd", "city": "Cleveland", "state": "OH", "postal_code": "44143-2131", "additional_info_contact": "440-483-7600", "reason_for_recall": "Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical.", "root_cause_description": "Software design", "action": "Philips Healthcare sent an Field Safety Notice dated August 16. 3013, via certified mail to all US customers. Market Representative will distribute the letter internationally. The letter identified the product the problem and the action needed to be taken by the customer.\r\n\r\nField Safety Notice 88200460 is intended to inform you about;\r\n\" what the problem is and under what circumstances it can occur\r\n\" the actions that should be taken by the customer / user in order to prevent risks for patients or users\r\n\" the actions planned by Philips to correct the problem\r\n\r\nAdditionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.\r\n\r\nIf you need any further information or support concerning these issues, please contact your local Philips representative or local Philips Healthcare office.\r\nFor North America and Canada contact the Customer Care Solutions Center \r\n(1-800.722.9377, option 5: Enter Site ID or follow the prompts).", "product_quantity": "13", "distribution_pattern": "Worldwide Distribution - US (nationwide) including the states of NY, OH and Pa, and the countries of 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