{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Orange City",
      "state": "IA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82641",
      "recalling_firm": "Med Tec Inc",
      "address_1": "1401 8th St SE",
      "address_2": "N/A",
      "postal_code": "51041-7463",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - US Nationwide distributed in the states of CA, HI, PA, KY, FL, WI, AK and countries of Australia, Canada, Italy, Netherlands, Switzerland, Peru.",
      "recall_number": "Z-1837-2019",
      "product_description": "CIVCO Solstice(TM) SRS Immobilization System, Part Numbers:  a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to approximately 10¿ in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeter. The provider can correct the patient position for simulation and treatments by tilting the device.",
      "product_quantity": "28 units",
      "reason_for_recall": "There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.",
      "recall_initiation_date": "20190415",
      "center_classification_date": "20190618",
      "termination_date": "20201005",
      "report_date": "20190626",
      "code_info": "Part Numbers:    a) CHS03, UDI 00841439112489  Lot Numbers:  M602380, M680480, M847590, M870360  b) CHS04, UDI 00841439112496  Lot Numbers:  M680530, M789100, M789110, M839690, M938500"
    }
  ]
}