{ "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": "130747", "product_res_number": "Z-0183-2015", "event_date_initiated": "2014-09-23", "event_date_posted": "2014-11-07", "recall_status": "Terminated", "event_date_terminated": "2017-05-08", "res_event_number": "69480", "product_code": "IZI", "k_numbers": [ "K073290" ], "product_description": "Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.", "code_info": "model number 10280959, with serial numbers 1000-1599", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "51 Valley Stream Pkwy", "city": "Malvern", "state": "PA", "postal_code": "19355", "additional_info_contact": "Customer Support\n610-219-6300", "reason_for_recall": "A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routing of the cable may result in increased wear over time. Without additional measures, the potential exists for a cable inside the C-arm to break which could result in restricted functionality or system failure and an ongoing procedure could be terminated. Additionally, a subgroup of affected C-arm systems will receive a replacement of the cable harness.", "root_cause_description": "Device Design", "action": "Siemens sent an \" Important Safety Information \" letter dated September 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\nSiemens will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services.\n\nOur service organization will contact with you to schedule an appointment to perform the corrective action. Please feel free to contact our service organization for an earlier appointment.\n\nPlease observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions, please call (610) 219-6300.", "product_quantity": "164", "distribution_pattern": "Nationwide Distribution including Puerto Rico.", "openfda": { "k_number": [ "K972136", "K130003", "K850455", "K915199", "K955519", "K875376", "K945400", "K875374", "K897115", "K875184", "K913685", "K182907", "K955179", "K984545", "K954581", "K991231", "K972655", "K810183", "K812238", "K222240", "K875375", "K880690", "K100371", "K892849", "K935026", "K170239", "K932410", "K910654", "K931184", "K151780", "K933058", "K062360", "K925961", "K180019", "K190772", "K993765", "K945449", "K945540", "K073290", "K842494", "K041027", "K905653", "K953563", "K230727", "K073088", "K082907", "K960575", "K974367", "K010721", "K934496", "K253181", "K903941", "K130842", "K973482", "K922222", "K042646", "K993947", "K052076", "K920434", "K945375", "K920705", "K993763", "K033184", "K041949", "K945459", "K903371", "K133993", "K090745", "K955395", "K970738", "K072591", "K073328", "K875380", "K261037", 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