{
  "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": "168762",
      "product_res_number": "Z-0388-2019",
      "event_date_initiated": "2018-09-10",
      "event_date_created": "2018-11-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-05-12",
      "res_event_number": "81454",
      "product_code": "REM",
      "product_description": "DeltaVision OMX SR Imaging System Model Number: 29115476\n\n The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and localization microscopy may be used to examine a variety of samples over long periods of time.",
      "code_info": "System Serial number OM20072 - OM40122",
      "firm_fei_number": "1281317",
      "recalling_firm": "GE Healthcare Biosciences",
      "address_1": "14 Walkup Dr",
      "city": "Westborough",
      "state": "MA",
      "postal_code": "01581-1019",
      "additional_info_contact": "508-475-2000",
      "reason_for_recall": "Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.",
      "root_cause_description": "Device Design",
      "action": "The firm, GE Healthcare, sent an \"Important Electronic Product Radiation Warning\" letter to affected customers on September 10, 2018.  The letter identified the affected product, problem and actions to be taken.  GE Healthcare will, without charge, remedy the defect or bring the product into compliance.  Your GE Service Representative will contact you to implement the correction.  \n\nFor questions contact your local GEHC service representative or call  425-657-1512 or email:  trisha.koenke@ge.com.",
      "product_quantity": "39",
      "distribution_pattern": "Worldwide - US Nationwide Distribution",
      "openfda": {
        "device_name": "Spectroscopy Instrument",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}