{
  "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": "178195",
      "product_res_number": "Z-0870-2020",
      "event_date_initiated": "2019-09-27",
      "event_date_created": "2020-01-29",
      "recall_status": "Open, Classified",
      "res_event_number": "84378",
      "product_code": "REK",
      "product_description": "EQ-400-RH-QZ and EQ-400-LH-BK products \n\nProduct Usage:  The device is a very broadband light source emitting incoherent non-laser light from the Deep UV through the visible wavelengths.",
      "code_info": "The defect concerns a total of fifteen (15) of our EQ-400 products. manufactured between June 3, 2016 and September 26, 2019.",
      "firm_fei_number": "3005152898",
      "recalling_firm": "Energetiq Technology Inc",
      "address_1": "7 Constitution Way",
      "city": "Woburn",
      "state": "MA",
      "postal_code": "01801-1024",
      "reason_for_recall": "On September 27, 2019 Energetiq Technology (the manufacturer) discovered a problem with\ntheir EQ-400-RH-QZ and EQ-400-LH-BK products during routine manufacturing functional\ntesting. It was noted that a safety interlock within the lamp does not function in a reliable manner\nto shut down the system if the laser collimator is removed from the lamp while the system is\noperating. This is a potential safety hazard for anyone working on or nearby the lamp.",
      "root_cause_description": "Device Design",
      "action": "On  October 28, 2019 Recall notification letters were sent to all customers of record that  purchased the affected unit.  The letter identified the affected product, problem and actions to be taken.  Pending resolution of this issue we would advise all users if EQ-4001 units to follow the Operational Requirements that are attached to this letter. Specifically DO NOT REMOVE THE LASER COLLIMATOR FROM THE LAMP WHILE THE SYSTEM IS OPERATING. We have also enclosed a safety label and bolt caps with installation instructions.\nThe manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of H Health and Human Services, the details of which will be included in a subsequent communication to you.",
      "product_quantity": "15",
      "distribution_pattern": "Worldwide Distribution.",
      "openfda": {
        "device_name": "Research Laser",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}