{ "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": "216490", "product_res_number": "Z-0462-2026", "event_date_initiated": "2025-10-01", "event_date_posted": "2025-11-07", "recall_status": "Open, Classified", "res_event_number": "97748", "product_code": "JAA", "k_numbers": [ "K232910" ], "product_description": "CombiDiagnost R90;\nModel Number: 709031;", "code_info": "Model Number: 709031;\nUDI-DI: 00884838101456;\nSerial Number: 100001385, 100001402, 100001409, 100001412, 100001415, 100001416, 100001417, 100001424, 100001426, 100001432, 100001449, 100001460, 100001464, 100001476, 100001480, 100001483, 100001488;", "firm_fei_number": "3003768251", "recalling_firm": "Philips Medical Systems DMC GmbH", "address_1": "24 development and manufacturing ctr. rontgenstr.", "city": "Hamburg", "country": "Germany", "additional_info_contact": "Customer Care Solution Center\n1-800-7229377", "reason_for_recall": "Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024\nthrough June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required\nfor manual movement) due to potential manufacturing issues.", "root_cause_description": "Device Design", "action": "On October 1, 2025, \"URGENT MEDICAL DEVICE CORRECTION\" letters dated September 30, 2025, were sent to customers. The letters described the problem, product and actions to be taken. Actions to be taken: It is safe to continue to use the system(s) in accordance with the intended use.\n It is recommended that customers use the motorized movement option until the technical solution has been implemented.\n The system may experience motor drive errors if the force for movement exceeds 110N, which restricts the motorized movement. If the motorized movement does not function, customers should contact their local service representative.\nB. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm.\nC. Please retain this Urgent Medical Device Correction letter with your system(s) until the solution is installed; ensure the notice is in a place likely to be seen/viewed.\n5. Actions planned by Philips to correct the problem.\n\nPhilips will provide the technical solution details when finalized.\nThis notice has been reported to the appropriate Regulatory Agencies.\n\nIf you need any further information or support concerning this issue, please contact your local Philips representative. For North America, contact the Customer Care Solutions Center (1-800-722-9377, 8AM 8PM EST, Monday-Friday).", "product_quantity": "17 units", "distribution_pattern": "Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,", "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", 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