{ "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": "204969", "product_res_number": "Z-0781-2024", "event_date_initiated": "2023-12-13", "event_date_posted": "2024-01-23", "recall_status": "Open, Classified", "res_event_number": "93614", "product_code": "KPR", "k_numbers": [ "K012546" ], "product_description": "Sedecal X Optima URS digital mobile diagnostic x-ray system. \n\nA a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.", "code_info": "All serial numbers, UDI-DI 08436046002500.", "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": "Devan Moser\n847-394-6960", "reason_for_recall": "Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.", "root_cause_description": "Equipment maintenance", "action": "On 12/13/2023, the recalling firm emailed the recall letter dated 12/11/2023 to their distributor customers along with attachments for service and maintenance of the units. The letter explained a description of the issue and that the installed devices should be inspected to ensure they are being used in a safe mode (the unit has been properly maintained and does not show any signs of the screws loosening) and to fix any potential issues. This inspection will also be included in all scheduled maintenance tasks to be performed in the future. The letter is to be distributed to all staff involved. The letter included 3 attachments. Annex 1 contains further information regarding the issue. Annex 2 is the acknowledgement of receipt of the notification and understanding of the described problem and its importance. Annex 3 is confirmation that the mandatory field checks or upgrade of the affected unit is complete.\n\nThe firm reported distributors will provide the information to the medical facility either by using the recalling firm's letter or creating a new letter.", "product_quantity": "845 units", "distribution_pattern": "Distribution was made to AL, FL, and NC. There was no military/government distribution.", "openfda": { "k_number": [ "K193637", "K102285", "K152767", "K033345", "K981056", "K071430", "K190601", "K012546", "K250954", "K082261", "K833559", "K973710", "K192453", "K201725", "K080614", "K190330", "K953832", "K061595", "K945709", "K904676", "K151924", "K233532", "K180543", "K902378", "K173517", "K910757", "K071401", "K172869", "K942792", "K121513", "K103448", "K811230", "K931071", "K771051", "K870300", "K072659", "K760205", "K250788", "K140326", "K102349", "K220271", "K921539", "K133959", "K101042", "K091752", "K781983", "K082064", "K121345", "K233381", "K202394", "K231995", "K181279", "K942581", "K122589", "K250738", "K800564", "K220518", "K811807", "K083503", "K952871", "K920347", "K913435", "K012389", "K052943", "K201825", "K922813", "K963941", "K062405", "K880982", "K213700", "K011486", "K083640", "K040995", "K101779", "K103050", "K203537", "K926069", "K202293", "K233722", "K141837", "K182134", "K083109", "K926554", "K202388", 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