{ "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": "175626", "product_res_number": "Z-0148-2020", "event_date_initiated": "2019-07-30", "event_date_created": "2019-10-16", "recall_status": "Terminated", "event_date_terminated": "2022-06-10", "res_event_number": "83529", "product_code": "JGS", "k_numbers": [ "K151767" ], "product_description": "Siemens Atellica CH 930 Analyzer. \nSiemens Material Number (SMN): 11067000\n\nProduct Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens", "code_info": "Software version: V1.19.2 and below", "firm_fei_number": "2432235", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "511 Benedict Ave", "city": "Tarrytown", "state": "NY", "postal_code": "10591-5005", "additional_info_contact": "SAME\n914-631-8000", "reason_for_recall": "Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below", "root_cause_description": "Software design", "action": "Siemens issued an Urgent medical Device Correction, (UMDC ASI19-02.A.US) via Fed Ex and Urgent Field Safety Notification (UFSN ASI19-02.A.OUS) to all affected Customers beginning on 2019-07-30. The UFSN/UMDC explain the behaviors that can occur and instructs customers on actions to be taken for the issues described in the communication. Customers are requested to return the attached effectiveness check form via fax or email within 30 days. Field Service personnel will be sent a Service Knowledge Base describing the issue and instructing them how to deal with customer questions.", "product_quantity": "1125 units", "distribution_pattern": "Worldwide Distribution - US Nationwide\nForeign:\nArgentina\nAustralia\nAustria\nBangladesh\nBelgium\nBrazil\nBulgaria\nCanada\nChile\nColombia\nCzech Republic\nDenmark\nEcuador\nEgypt\nFinland\nFrance\nGermany\nGreece\nHungary\nIndia\nIndonesia\nIran\nIreland\nIsrael\nItaly\nJapan\nKuwait\nLatvia\nMalaysia\nMexico\nNetherlands\nNigeria\nNorway\nP.R. 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