{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "167129", "product_res_number": "Z-0300-2019", "event_date_initiated": "2018-08-06", "event_date_created": "2018-10-30", "recall_status": "Terminated", "event_date_terminated": "2020-04-10", "res_event_number": "80960", "product_code": "KPR", "k_numbers": [ "K133259" ], "product_description": "Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.", "code_info": "Serial Numbers 24077 24221 24256 24237 24263 24327 24297 24283 24288 24289 24172 24174 24186 24129 24277 24142 24304 24109 24176 24049 24058 24039 24234 24323 24105 24295 24121 24230 24276 24194 24281", "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": "Anastasia Sokolova\n610-448-6478", "reason_for_recall": "In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This could lead to overloading the safety rope, which is not designed for continuous load and ongoing movement under load. This may lead 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": "Urgent Medical Device Correction notification letters dated 8/6/18 were distributed to customers. The letters instruct customers to do the following:\n\nTo avoid the above mentioned risk until implementation of the corrective action, 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.\n\nHow will the issue finally be resolved?\nSiemens Healthineers is preparing a corrective action that will resolve this potential issue. The corrective action will be distributed via an Update Instruction XP025/18/S and is planned to be available in the end of August 2018.\nHow will the corrective action be implemented and how effective is the corrective action?\nOur service organization will contact you shortly to arrange a date to perform this corrective action with Update Instruction XP025/18/S. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.", "product_quantity": "31", "distribution_pattern": "The products were distributed to the following US states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NM, NV, NY, OH, OK, PA, PR, SC, SD, TX, UT, VA, WI, and WY.", "openfda": { "k_number": [ "K071402", "K071401", "K102349", "K800788", "K220149", "K013826", "K190330", "K213700", "K122454", "K803049", "K953832", "K180663", "K182183", "K063246", "K182880", "K082798", "K841756", "K790069", "K071546", "K970136", "K192364", "K022737", "K231761", "K172869", "K182517", "K790685", "K192541", "K936087", "K921112", "K110828", "K113248", "K853753", "K854110", "K083503", "K172229", "K790070", "K242499", "K210692", "K933778", "K093816", "K091889", "K233719", "K973219", "K203537", "K181629", "K102285", "K082261", "K122726", "K182134", "K972766", "K880982", "K870400", "K072659", "K180765", "K101686", 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