{ "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": "130745", "product_res_number": "Z-0854-2015", "event_date_initiated": "2014-09-17", "event_date_posted": "2015-01-14", "recall_status": "Terminated", "event_date_terminated": "2015-08-06", "res_event_number": "69478", "product_code": "IZI", "k_numbers": [ "K073290" ], "product_description": "Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems 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 numbers: 10094135, 10094137, 10094139, 10094141, 10280959, with serial numbers: 160348 146643 147129 146630 147208 146972 153707 147378 146742 157650 146986 147098 157696 153946 146940 147144 147029 160384 153884 147009 153628 153706 146729 147155 153790 146896 153757 136503 147372 136345 153762 146883 160421 153195 146427 153834 135927 154157 135862 153998 153257 153220 153682 160341", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "40 Liberty Blvd Mail Code 65-1A", "city": "Malvern", "state": "PA", "postal_code": "19355-1418", "additional_info_contact": "Customer Support\n610-219-6300", "reason_for_recall": "The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual switchover is needed, resulting in a short interruption of the procedure.", "root_cause_description": "Process control", "action": "Planned action (s) to repair defect or to bring product into compliance for Siemens Medical Solutions Inc. concerning the corrective action plan (CAP) for the Model(s) Artis Zee/Zeego Stationary Angiographic X-ray Systems.\n\n1.Notifying the customer of the defect.\n2.Implementing a corrective software patch to protect the system from damage in\nthe event of hardware failure\n3. Scheduling a service visit from a Siemens representative to perform a hardware replacement.\n4. Replacing the non-conforming X-ray tube with one manufactured after the nonconformity issue was resolved.\n\nFor further questions please call (610) 219-6300.", "product_quantity": "44", "distribution_pattern": "USA Distribution to the states of MO, MI, NY, OK, CA, LA, CT, IN, VA, MD, WA, HI, ME, TX, NY, OH, PA and CO.", "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", 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