{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Waukesha",
      "address_1": "3000 N Grandview Blvd",
      "reason_for_recall": "GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.",
      "address_2": "",
      "product_quantity": "29",
      "code_info": "25018 816234D640  26004 815564O640  26007 817250NM640  26010 717782640NM  26012 808485NM640  26013 847872O640  26014 901516GO640  26018 270956NM640  26020 309672NM2  26021 215728OPT640  26025 410543NUC640  26026 928214NMCT  26028 715735OPT1  26002 0910263256  26005 0910263253  22020 030232NU15  26009 DK1054NM03  26001 XM203401  26003 ULUE01NU02  26015 915839NU01  26024 083026800008113  26006 A5639613  26008 A5366308  25023 RTD0782  26030 NM26030  26023 BD003NU01  26017 00162NUC11  26019 00203NUC06  26022 00139NUC08",
      "center_classification_date": "20141107",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.",
      "state": "WI",
      "product_description": "Optima NM/CT 640, Models H3100YA, H3100YC.       Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies",
      "report_date": "20141119",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "GE Healthcare, LLC",
      "recall_number": "Z-0188-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "69570",
      "termination_date": "20150227",
      "more_code_info": "",
      "recall_initiation_date": "20141014",
      "postal_code": "53188-1615",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}