{
  "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": [
    {
      "status": "Terminated",
      "city": "Waukesha",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82582",
      "recalling_firm": "GE Healthcare, LLC",
      "address_1": "3000 N Grandview Blvd",
      "address_2": "N/A",
      "postal_code": "53188-1615",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK",
      "recall_number": "Z-1266-2019",
      "product_description": "Optima NM/CT 640    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.",
      "product_quantity": "35 units",
      "reason_for_recall": "During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.",
      "recall_initiation_date": "20190320",
      "center_classification_date": "20190502",
      "termination_date": "20201005",
      "report_date": "20190508",
      "code_info": "Mfg. Lot or Serial # System ID Model, Catalogue or Code #  ONMX26520 714456OPT1 5474055  ONMX26518 408559O640 H3100JZ  ONMX26529 408559O640 H3100JZ  ONMX26528 970298NM 5474055  ONMX26537 303425O640 5474055  ONMX26538 303689O640 5474055  ONMX26539 970298NM1 5474055  ONMX26519 860358O640 H3100JZ  ONMX26530 302430NUC640 H3100JZ  ONMX26512 515699NM1 H3100JZ  ONMX26503 630933NM6402 H3100JZ  ONMX26513 316962NM640 H3100JZ  ONMX26511 443777NM 5474055  ONMX26542 301315NMOPTIMA H3100JZ  ONMX26510 906225NMCT H3100JZ  ONMX26514 4695537NM11 H3100JZ  ONMX26507 RMCOPTIMA H3100JZ  ONMX26515 701239NM640B 5474055  ONMX26534 402473OPT640 H3100JZ  64GX51001 SHIPPED (GON 4562299) H3101RL  64GY51006 SHIPPED (AO 1635868) H3101RL  64GY51007 SHIPPED (GON 4562663) H3101RL  ONMX26544 740593OPT640 H3100JZ  ONMX26531 614MCMN640 5474055  ONMX26517 513870NM640 H3100JZ  ONMX26524 614GCNM6402 5474055  ONMX26527 614GCNM640 H3100JZ  ONMX26546 605347NM640 H3100JZ  ONMX26516 469993NM H3100JZ  ONMX26476 608263OPT640 H3100JZ  ONMX26480 403529D640 H3100JZ  ONMX26502 4534444NM12 H3100JZ  ONMX26536 HR4052NM03 H3100JZ  ONMX26521 NTE042 H3100JZ  ONMX26525 ZA2719CT01 H3100JZ"
    }
  ]
}