{ "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": "167219", "product_res_number": "Z-0297-2019", "event_date_initiated": "2018-08-03", "event_date_created": "2018-10-30", "recall_status": "Terminated", "event_date_terminated": "2019-11-26", "res_event_number": "81007", "product_code": "KPR", "k_numbers": [ "K121513" ], "product_description": "Multix Fusion system is a radiographic system:\nModels:\nMultix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059);\nMultix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042);\nMultix Fusion Digital Integrated (model number 10746667) with Tube stand 3D V (model number 7042042);\nMultix Fusion Digital Wireless (model number 10893300) with Tube stand 3D V (model number 7042042)", "code_info": "Serial Numbers:  40279 10037 1176 40026 1220 40106 40208 40209 40109 40114 40140 40104 40126 40144 10040 10041 40027 40118 40105 40128 40200 40146 10039 40102 40101 40022 40125 40142 40127 40117 40206 1192 1185 40116 40119", "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": "Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning", "root_cause_description": "Device Design", "action": "Siemens Healthineers issued Urgent Medical Device Correction notice dated August 3, 2018, informing potentially affected users via Safety Advisory Notice XP029/18/S to advise of the problem, risk to health, action to be taken (it is strongly recommended not to perform up/down movements of the lifting column directly above the patient. Instead, the vertical movement should be completed beside the patient and then the system should be moved horizontally to the patient).\nThe service organization will contact to arrange a date to perform this corrective action with Update Instruction XP031/18/S. Contact service organization for an earlier appointment at 1-800-888-7436.\n\nSiemens Healthineers is preparing a corrective action that will resolve this potential issue. The corrective action will be distributed via an Update Instruction XP031/18/S.", "product_quantity": "35 units", "distribution_pattern": "US nationwide 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", 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