{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "118015",
      "product_res_number": "Z-0433-2014",
      "event_date_initiated": "2013-05-10",
      "event_date_posted": "2013-12-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-08-26",
      "res_event_number": "65147",
      "product_code": "NSX",
      "product_description": "syngo(R) Lab Data Manager - Version VA11B and VA12A Systems\n\nSecurely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help keep systems running optimally and also has audit trail capabilities.",
      "code_info": "Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)",
      "firm_fei_number": "2517506",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr Ms 514",
      "address_2": "PO BOX 6101",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19702-2466",
      "additional_info_contact": "Customer Support\n800-441-9250",
      "reason_for_recall": "Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.",
      "root_cause_description": "Software design",
      "action": "Siemens sent an Urgent Medical Device Correction letter in May 2013 to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to review the letter in its entirety and ensure that all operators understand the information presented.  Specific actions needed to be implemented by the customer were  outlined in the letter.  Customers were instructed to retain the letter with their laboratory records, and forward the letter to those who may have received the affected product.  Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative.\nFor questions regarding this recall call 800-441-9250.",
      "product_quantity": "262",
      "distribution_pattern": "Worldwide Distribution: USA (nationwide) and internationally to Canada.",
      "openfda": {
        "registration_number": [
          "2024500",
          "3031158",
          "9611109",
          "1528142",
          "9611031",
          "3003587684",
          "3003971136"
        ],
        "fei_number": [
          "2024500",
          "3002807019",
          "1000122772",
          "3000215024",
          "3002808267",
          "3003587684",
          "3003971136"
        ]
      }
    }
  ]
}