{ "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": "214871", "product_res_number": "Z-0249-2026", "event_date_initiated": "2025-06-10", "event_date_posted": "2025-10-23", "recall_status": "Open, Classified", "res_event_number": "97075", "product_code": "IZL", "k_numbers": [ "K161345" ], "product_description": "Model Number 40KWFXPLUS.005, Mobile X-ray system", "code_info": "UDI/DI 08436046002166, Serial Numbers: G82576, G82871, G72391, G74872, G75722, G76782, G75035, G75723, G78884, G70532, G73630, G82077.", "firm_fei_number": "3002495042", "recalling_firm": "SEDECAL SA", "address_1": "Pelaya, 9 Pol. Pelaya 9 Pol. Pol. Ind. Rio De Janeiro", "city": "Algete", "country": "Spain", "additional_info_contact": "Marie Luisa Gomez de Aguero\n8473946960", "reason_for_recall": "Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.", "root_cause_description": "Device Design", "action": "Sedecal emailed their distributors on 06/10/2025 to remind them the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. on 09/19/2025 the firm issued an Important Safety Notice to its direct consignees via email. This notice initiates Phase 2 of the recall strategy expanding the scope and providing information on stickers to cover gaps around the fine positioning control buttons and a DMC software update that stops unit movement if triggered by a short cicuit or prolonged button press with instructions. Consignees will be contacted by a Sedecal Customer support Service to coordinate the shipment of the necessary conversion kits (quantity and delivery address) to allow upgrading the affected units.", "product_quantity": "12 units", "distribution_pattern": "US: CA, IL, and NJ", "openfda": { "k_number": [ "K170607", "K781676", "K862118", "K203658", "K191025", "K173187", "K240841", "K232185", "K234108", "K781425", "K001517", "K162278", "K142492", "K022337", "K052897", "K111725", "K210982", "K002685", "K955095", "K923359", "K203667", "K240284", "K222896", "K781705", "K790451", "K972204", "K930699", "K222258", "K202350", "K970234", "K931279", "K781982", "K873982", "K212291", "K811082", "K121410", "K062472", "K201575", "K810276", "K202353", "K222339", "K242515", "K790392", "K090655", "K780313", "K182234", "K891143", "K082627", "K052721", "K012663", "K992229", "K912400", "K052001", "K211423", "K760741", "K212515", "K250750", "K221803", "K181626", "K211473", "K060566", "K071015", "K251443", 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