{ "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": "190257", "product_res_number": "Z-0331-2022", "event_date_initiated": "2021-10-15", "event_date_created": "2021-12-02", "recall_status": "Terminated", "event_date_terminated": "2024-05-13", "res_event_number": "89008", "product_code": "JJE", "k_numbers": [ "K051087", "K143720" ], "product_description": "Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid\nSMN: 10284473 (US) and 10488224 (OUS)", "code_info": "All software versions prior to 3.10.2.\nGTIN: 00630414949581 and 00630414989556 \n(GTIN + Instrument Serial Number = Unique Device Identification (UDI)", "firm_fei_number": "2517506", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "500 Gbc Dr", "city": "Newark", "state": "DE", "postal_code": "19702-2466", "additional_info_contact": "SAME\n800-441-9250", "reason_for_recall": "Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays", "root_cause_description": "Software design", "action": "Siemens issued Urgent Medical Device Correction letter dated 10/27/21 to US Customers (VSW-22-01.A.US) and OUS Customers will be sent Urgent Field Safety Notice (VSW-22-01.A.OUS) to inform them of the issue and instruct them on setting the HIL index for the affected assays if applicable. The Dimension Vista software has been updated with the correct HIL index default settings recommended in this letter and included in software version 3.10.2. Letter states reason for recall, health risk and action to take:\nFor the products listed in Table 1, please perform the following steps if the HIL feature is activated\non your Dimension Vista System. If your laboratory is not using the HIL feature and it is not\nactivated on your system no action is required:\nIf the HIL indices for Dimension Vista FOL are activated, be sure to set the I index (icterus)\nto 6 which is aligned with the information in the Dimension Vista FOL IFU.\nIf the HIL indices for Dimension Vista AMM are activated, be sure to set the L index\n(lipemia) to 2 which is aligned with the information in the Dimension Vista AMM IFU.\nNote: Instructions for setting HIL indices can be found in the Dimension System\nOperator s Guide, in Section Configuration, System Configuration.\nIf the HIL indices for Dimension Vista CTNI are activated, be sure to set the I index (icterus)\nto 7 which is aligned with the information in the Dimension Vista CTNI IFU.\nIf the HIL indices for Dimension Vista TPSA and/or FPSA are activated, be sure to set the H\nindex (hemolysis) to 7 and the I index (icterus) to 6 which is aligned with the information in\nthe Dimension Vista TPSA and FPSA IFUs.\nPlease review this letter with your Medical Director.\nComplete and return the Field Correction Effectiveness Check Form attached to this letter\nwithin 30 days to Siemens Healthineers for reporting to the Authorities.\nIf you have received any complaints of illness or adverse events associated with the\nproduct listed in Table 1, immediately contact your lo", "product_quantity": "1326 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of DE, ES, FR, IT, \nCA, NL, JP, PT, AU, CZ, AT, DK, SI, BE, SK, QA, SA, KR, CH.", "openfda": { "k_number": [ "K130915", "K946090", "K833067", "K920402", "K904219", "K830212", "K945271", "K831477", "K843059", "K945135", "K790072", "K883209", "K073370", "K772319", "K910185", "K961481", "K830762", "K063144", "K040958", "K922139", "K800085", "K852133", "K832584", "K890184", "K843283", "K870833", "K893776", "K771245", "K840501", "K842500", "K811194", "K922680", "K782014", "K945566", "K853391", 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