{ "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": "168865", "product_res_number": "Z-0457-2019", "event_date_initiated": "2018-10-19", "event_date_created": "2018-11-14", "recall_status": "Terminated", "event_date_terminated": "2020-04-27", "res_event_number": "81514", "product_code": "IZI", "k_numbers": [ "K073290" ], "product_description": "ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system\n\nProduct Usage:\nArtis zee 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 with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.", "code_info": "Serial Numbers: Serial 155122 155149 155151 155105 155148 154671 155126 155131 155132 155119 155121 155118 155147", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "40 Liberty Blvd", "city": "Malvern", "state": "PA", "postal_code": "19355-1418", "additional_info_contact": "SAME\n610-219-4834", "reason_for_recall": "Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support", "root_cause_description": "Device Design", "action": "Siemens issued on 10/19/18 an Urgent Medial Devoce Correction notification to via AX033/18/S advising users of the problem, health risk, steps to be taken. \nSiemens has initiated screw connection exchange of the ceiling bearing via Update Instruction AXOSS/17 /S.", "product_quantity": "14 units", 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