{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "193661", "product_res_number": "Z-1243-2022", "event_date_initiated": "2022-04-13", "event_date_posted": "2022-06-06", "recall_status": "Open, Classified", "res_event_number": "90175", "product_code": "DQK", "k_numbers": [ "K150493" ], "product_description": "Sensis, Programmable Diagnostic Computer, Model Nos.\t6623974 6634633\n6634658 6648153\n6648161 10140973\n10764561 10765502\n10910620", "code_info": "UDI-DI: 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8/31/22 - the following units have been removed from the scope of this correction ***\n\n6634633\t20314\n6634633\t20102\n6634633\t20149\n6634633\t2506\n6634633\t2709\n6634633\t2739\n6634633\t3072\n6634633\t21212\n6634633\t3622\n6634633\t3670\n6634633\t3676\n6648161\t18103\n6648161\t18104\n10764561\t61230\n10764561\t61232\n6634633\t2434\n10764561\t61088\n10765502\t15130\n6634633\t20594\n6634633\t20637\n6634633\t22611\n6634633\t3319\n10765502\t15146\n10765502\t15001\n6634633\t20033\n6634633\t22509\n10140973\t13272\n6648161\t18105\n10764561\t61234\n6648153\t16005\n6634633\t2203\n10764561\t60359\n6634633\t20133\n6648153\t16001\n6648161\t11053\n10764561\t61136\n6648161\t18101\n6634633\t21395\n10765502\t15013\n10765502\t15106\n10910620\t14117\n10910620\t14119\n6634633\t2442\n6634633\t2444\n6634633\t2500\n6634633\t2501\n10764561\t61031\n6634633\t3069\n\n***Updated 11/9/22 - The following systems have been added to this correction***\n\n6634633\t3136\n10140973\t13253\n\n***Updated 1/13/23 - Added the following system***\n\nMaterial Serial\n6623974\t42320", "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": "Meredith Adams\n610-219-4834", "reason_for_recall": "Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.", "root_cause_description": "Software Design Change", "action": "On April 13, 2022, the firm notified customers via an Urgent Medical Device Correction letter. Customers were informed of the software issues. the software in the affected systems will be updated to correct the issue. Siemens' service organization will contact customers to arrange a date to perform the corrective action. \n\nPlease feel free to contact Siemens' service organization for an earlier appointment at 1-800-888-7436.", "product_quantity": "443", "distribution_pattern": "Domestic distribution nationwide.", "openfda": { "k_number": [ "K112007", "K243842", "K130750", "K120550", "K042999", "K252429", "K133305", "K262006", "K081484", "K042799", "K223127", "K110549", "K013032", "K082467", "K181720", "K031000", "K100362", "K072752", "K014108", "K231035", "K921216", "K022188", "K212061", "K974192", "K900814", "K902716", "K240509", "K042849", "K173977", "K883152", "K191660", "K201181", "K110746", "K162793", "K251344", "K864583", "K190106", "K043564", "K001305", "K220243", "K230884", "K251234", "K093092", "K012020", "K201060", "K231091", "K000248", "K093566", "K183128", "K232616", "K123295", "K220306", "K141050", "K241197", "K021906", "K253034", "K142681", "K190593", "K013083", "K253186", "K161465", 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