{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Waukesha",
      "address_1": "3000 N Grandview Blvd",
      "reason_for_recall": "GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems.  While performing fluoroscopy on a biplane fluoroscopy unit, there is a potential for loss of the x-ray imaging function when the user changes the size of the lateral FOV (Field of View) and releases the biplane footswitch pedal simultaneously. This could lead to a system lock up requiring",
      "address_2": "",
      "product_quantity": "28 (12 US, 16 OUS).",
      "code_info": "Serial #                   System ID  00000616724BU1 956389IGS630  00000618156BU4 MCMIGS630  FMI12200DUMMY2 702731ANGIO2  00000619372BU6 732828IGS30  00000618158BU0 210705CATH1  00000622076BU9 661327IGS630  00000621314BU4 904202WCL2  00000628656BU1 281MHWCL1  00000622220BU2 303839CL4  00000625357BU9 281420LAB3BP  00000626085BU5 817BGIGS630  00000628654BU6 215576IGS4  FMI12200DUMMY3 CS1340VA01  00000614683BU1 M4152252  00000618160BU6 YV1900  00000617143BU3 YV1901  00000618157BU2 YV1902  00000620495BU2 YV1903  00000624842BU1 YV1904  00000627935BU0 YV1905  00000630300BU2 YV1906  00000617142BU5 YV1950  FMI12200DUMMY4 YV1907  00000622672BU4 850060746  00000626239BU8 850060749  FMI12200DUMMY1 SA2308VA01  00000622221BU0 ZA2239VA01  00000614682BU3 34006VAS02",
      "center_classification_date": "20140128",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of CA, CO, FL, NV, NJ, PA, TX and the countries of CZECH REPUBLIC, FRANCE, JAPAN, REPUBLIC OF KOREA, SAUDI ARABIA, and TURKEY.",
      "state": "WI",
      "product_description": "GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System.    Product Usage:  The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. The Cathiab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution. The Cathiab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify\u0019 the end-to-end clinical workflow in the cathlab by implementing: 1) Communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices. 2) Communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface. 3) Interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems.",
      "report_date": "20140205",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "GE Healthcare, LLC",
      "recall_number": "Z-0853-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67325",
      "termination_date": "20140328",
      "more_code_info": "",
      "recall_initiation_date": "20131115",
      "postal_code": "53188-1615",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}