{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Uppsala",
      "state": "",
      "country": "Sweden",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97872",
      "recalling_firm": "C-RAD POSITIONING AB",
      "address_1": "Bredgrand 18",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "The software module cSRS has been installed in 37 countries  Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, CA, CT, FL, MO, NC, NM, NY, OH, OK, OR, PA, TN, TX, VA, and WA. The countries of Argentina, Australia, Austria, Belarus, Belgium, Benin, Canada, China, Colombia, Egypt, El Salvador, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Mexico, Morocco, Netherlands, New Zealand, Norway, Portugal, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, and Vietnam.",
      "recall_number": "Z-1092-2026",
      "product_description": "Brand Name: Catalyst+  Product Name: Catalyst, Catalyst+  Model/Catalog Number: SP001-0026, SP003-0002  Software Version: cSRS module in combination with cMotion module  Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser  Component: Not applicable",
      "product_quantity": "189",
      "reason_for_recall": "Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance.",
      "recall_initiation_date": "20251009",
      "center_classification_date": "20260114",
      "report_date": "20260121",
      "code_info": "Lot Code: Note: The error is not related to any serial numbers or LOT numbers. The error is limited to the software module cSRS in combination with cMotion module",
      "more_code_info": ""
    }
  ]
}