{ "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": "169583", "product_res_number": "Z-0612-2019", "event_date_initiated": "2018-11-07", "event_date_created": "2019-02-12", "recall_status": "Terminated", "event_date_terminated": "2020-09-02", "res_event_number": "81706", "product_code": "JAA", "k_numbers": [ "K163210" ], "product_description": "Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030\n\nStationary Fluoroscopic X-ray System", "code_info": "All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2", "firm_fei_number": "3003768251", "recalling_firm": "Philips Medical Systems Gmbh, DMC", "address_1": "24 development and manufacturing ctr. rontgenstr.", "city": "Hamburg", "country": "Germany", "additional_info_contact": "Este Kinde\n678-2960248", "reason_for_recall": "kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.", "root_cause_description": "Software design (manufacturing process)", "action": "On November 7, 2018, Philips Medical Systems distributed an URGENT MEDICAL DEVICE RECALL\" notices dated 10/16/2018 to customers. \n\nThe following are Actions to Be Taken by the Customer:\n**If the kV/mA lockin not functioning as specified**:\nThe operator can recognize the issue by observing the increasing mA value.\nIn general the system can be used according to the Instruction for Use without\nrestrictions.\n\n**If the Stitching with SkyPlate aborts after first image**: \nThere are no actions to be taken by the user in these situations. The customer is notified at the end of the stitching run that the run failed. Customers can continue to use the device in accordance with this notice and the IfU.\n\nPhilips will provide an upgrade of all CombiDiagnost R90 systems in the field to Rel.1.0.3 (Eleva package incl. improved clinical EPX database).\nA Philips Service Engineer will contact you when the Field Action Kit is available\nto be implemented. Should you need to communicate with Philips with regard to this program, please reference Field Change Order 70900042.\n\nIf you need any further information or support concerning this issue, please\ncontact your local Philips representative: Technical Support Line: 1-800-722-9377.", "product_quantity": "146", "distribution_pattern": "Worldwide Distribution: US (nationwide) to states of: AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT & VA; and to countries of: Australia, Austria, Bangladesh, Belgium, Chile C¿te D'Ivoire, Czech Republic. Egypt, Ethiopia, France, Germany, Ghana, Iran, Italy, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Philippines, Portugal\nRussian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.", "openfda": { "k_number": [ "K905111", "K110785", "K904986", "K970608", "K191877", "K081091", "K904012", "K882311", "K813158", "K871119", "K912380", "K212145", "K233945", "K942264", "K182834", "K220871", "K052610", "K801948", "K061028", "K180589", "K082830", "K913886", "K961690", "K961207", "K811094", "K943532", "K827489", "K810716", "K851031", "K843972", "K771096", "K840390", "K880527", "K840364", "K203428", "K914525", "K123097", "K990055", "K843917", "K103038", "K232526", "K253103", "K200965", "K923137", "K973073", "K111292", "K840134", "K893644", "K012424", "K010772", "K963617", "K926122", "K812561", "K920721", "K901671", "K874901", "K915592", "K130318", "K021021", "K843235", 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