{ "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": "216352", "product_res_number": "Z-0241-2026", "event_date_initiated": "2025-09-29", "event_date_posted": "2025-10-23", "recall_status": "Open, Classified", "res_event_number": "97682", "product_code": "OWB", "k_numbers": [ "K183101" ], "product_description": "Zenition 50;\nProduct Number (REF): 718096; Interventional fluoroscopic x-ray system", "code_info": "Product Number (REF): 718096;\nUDI-DI: 00884838091535;\nAll serial numbers;", "firm_fei_number": "3002807880", "recalling_firm": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "address_1": "Veenpluis 4-6 4-6 veenpluis", "city": "Best", "country": "Netherlands", "reason_for_recall": "Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.", "root_cause_description": "Process control", "action": "On September 29, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Circulate this notice to all users and follow the instructions in the letter. 2. Affected systems may continue to be used in accordance with their intended use and Instructions for Use (IFU). 3. Ensure the letter is in a place likely to be seen/viewed. 4. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. 5. If you experience the issue described in this letter, please report it to your local Philips representative. Actions by Philips: Starting in October 2025, Philips will replace the 11W control board of the affected Zenition 50 systems.\nYour local Philips representative will contact you to schedule a visit to perform this activity in your system.", "product_quantity": "29 units", "distribution_pattern": "Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.", "openfda": { "k_number": [ "K201583", "K201172", "K223409", "K002198", "K002016", "K152928", "K092439", "K200218", "K093066", "K191503", "K100102", "K142273", "K201743", "K070123", "K121444", "K162614", "K172180", "K133819", "K203281", "K160455", "K260607", "K153232", "K230787", "K010942", "K130893", "K053279", "K220342", "K120282", "K092004", "K000221", "K171755", "K161563", "K233200", "K163140", "K023178", "K151598", "K060259", "K113027", "K170832", "K202431", "K181943", "K240020", "K181830", "K122457", "K232420", 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