{
  "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": "2026-08-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Plan-les-Ouates",
      "state": "",
      "country": "Switzerland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96233",
      "recalling_firm": "Medimaps Group",
      "address_1": "Fongit",
      "address_2": "Chemin des Aulx 18",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic: AL, AZ, CA, CO, DE, FL, IL, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY, OH, PA, SC, TX, UT, WA.  International: ALGERIA, ANDORRA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, CHILE, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, SOUTH KOREA, LEBANON, MALAYSIA, MEXICO, MONTENEGRO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY",
      "recall_number": "Z-1250-2025",
      "product_description": "Brand Name: TBS Osteo  Product Name: TBS iNsight  Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi  Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0  Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management  Component: No",
      "product_quantity": "2036 units (724 US, 1312 OUS)",
      "reason_for_recall": "Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.",
      "recall_initiation_date": "20250203",
      "center_classification_date": "20250228",
      "report_date": "20250312",
      "code_info": "UDI-DI: (1) B214OSTBSI3120, (2) B214OSTBSI3110, (3) B214OSTBSIV310, (4) B214OSTBSIV300.",
      "more_code_info": ""
    }
  ]
}