{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "104992", "product_res_number": "Z-0343-2012", "event_date_initiated": "2011-04-25", "event_date_posted": "2011-12-01", "recall_status": "Terminated", "event_date_terminated": "2013-02-22", "res_event_number": "60302", "product_code": "KPS", "k_numbers": [ "K081135" ], "product_description": "Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. \n\nThe GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine 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 organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.", "code_info": "The recalled GEMINI TF 16 system units are identified as follows: Model Number: 882470 and Model #882473, Serial Numbers: 7228, 7230, 7233, 7235, 7239, 7240, 7242, 7244, and 7237.", "firm_fei_number": "1525965", "recalling_firm": "Philips Medical Systems (Cleveland) Inc", "address_1": "595 Miner Road", "city": "Cleveland", "state": "OH", "postal_code": "44143-2131", "additional_info_contact": "440-483-7000", "reason_for_recall": "In response to complaints received by Philips Medical concerning certain identified software errors reported by their customers, the firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of the these PET/CT system units.", "root_cause_description": "Software design", "action": "Philips Healthcare sent a \"CPE CUSTOMER LETTER\" dated October 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Additionally, device operation information is provided to customers. A Philips Field Service Engineer will be visiting each customer site to install the necessary software upgrades. Contact the Customer Care Solutions Center at 1-800-722-9377 for questions concerning this notice.", "product_quantity": "9 units", "distribution_pattern": "Nationwide Distribution including the states of CO, LA, MD, MI, MN, PA, TX, VA, VT, and WI.", "openfda": { "k_number": [ "K981553", "K033254", "K926206", "K082506", "K093514", "K980715", "K042880", "K033782", "K123599", "K243186", "K011572", "K013353", "K923736", "K973396", "K991129", "K070589", "K041543", "K925186", "K936001", "K050366", "K162736", "K914296", "K161674", "K926133", "K261315", "K972509", "K121019", "K090178", "K201933", "K982387", "K181468", "K971878", "K123646", "K042863", "K221932", "K032063", "K013496", "K100714", "K172609", "K260524", "K925330", "K051549", "K923309", "K130451", "K110507", "K003882", "K253844", "K042903", "K923044", "K003849", "K982300", "K875378", "K060060", "K900892", "K954143", "K890100", "K081135", "K031705", "K921777", "K231731", "K222895", "K041218", "K141652", "K162337", "K963406", 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