{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "167661", "product_res_number": "Z-0302-2019", "event_date_initiated": "2018-09-04", "event_date_created": "2018-10-31", "recall_status": "Terminated", "event_date_terminated": "2020-05-05", "res_event_number": "81173", "product_code": "KPS", "k_numbers": [ "K123599" ], "product_description": "Vereos PET/CT, Software version 2.0.1.\nModel Number: 882446\n \nProduct Usage:\nThe Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.", "code_info": "Serial Numbers: 900004 900005 900006 900007 900008 900009 900010 900011 900012 900013 900014 900015 900016 900017 900018 900019 900020 900021 900022 900023 900024 900025 900026 900027 900028 900029 900030 900031 900032 900033 900034 900035 900036 900037 900038 900039 900040 900041 900042 900043 900044 900045 900046 900047 900048 900049 900050 900051 900052 900053 900054 900055 900056 900058 900059 900060 900062 900064 900065 900066 900067", "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": "Same\n440-483-7600", "reason_for_recall": "Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures; and Software errors that may result in partial set of images, inability to generate CT or PET images, incorrect scan parameters, or scanning the incorrect portion of the body.", "root_cause_description": "Software design", "action": "Philips notified customers of these issues through Customer Information Letter (CIL) 88200518 to U.S. customers on 9/04/18 receive via USPS Certified mail.\n notifying them about the issues and temporary solutions available.\n\nNon-U.S. customers Non-U.S. customers will receive the letter through Philips Global Markets following local regulations.\n\nField correction will consist of proactive field change order (FCO) release to be deployed to the impacted systems to correct all these issues.customers.\n\nif you need any further information or support concerning this issue, contact your local Philips representative.\nFor North America and Canada, contact the Customer Care Solutions Center (1-\n800-722-9377, follow the prompts).", "product_quantity": "61 units", "distribution_pattern": "US Nationwide Distribution", "openfda": { "k_number": [ "K101550", "K201807", "K921008", "K002584", "K940487", "K992731", "K101013", "K924498", "K981352", "K781753", "K210173", "K915470", "K241266", "K161631", "K090811", "K042467", "K013496", "K050366", "K935318", "K161740", "K892358", "K013504", "K180318", "K911078", "K911290", "K894998", "K960948", "K972509", "K992450", "K190900", "K942837", "K011611", "K083649", "K003882", "K010509", "K133657", "K193241", "K962481", "K041022", "K062450", "K221932", "K072567", "K021823", "K210001", "K003434", "K933321", "K141477", "K243186", "K090403", "K922373", "K003849", "K052640", "K033782", "K972686", "K925330", "K940236", "K873775", "K041182", "K130269", "K243538", "K051460", "K022872", "K852239", "K231748", "K040370", "K180514", "K241585", "K240827", "K922426", "K030199", "K171719", "K896458", "K980867", "K890100", "K023518", "K000908", 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