{
  "companyId": "60038",
  "slug": "ge-medical-systems-llc-60038",
  "name": "GE Medical Systems, LLC",
  "clearances": {
    "total": 328,
    "last12Months": 7,
    "first": "1989-05-22",
    "latest": "2026-06-24"
  },
  "medianReviewDays": 70,
  "productCodeCount": 40,
  "recalls": {
    "total": 235,
    "openLast12Months": 27,
    "recent": [
      {
        "resNumber": "Z-2726-2026",
        "productCode": "IZL",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-06-05",
        "reason": "GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam."
      },
      {
        "resNumber": "Z-2727-2026",
        "productCode": "IZL",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-06-05",
        "reason": "GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam."
      },
      {
        "resNumber": "Z-2728-2026",
        "productCode": "IZL",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-06-05",
        "reason": "GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam."
      },
      {
        "resNumber": "Z-2475-2026",
        "productCode": "FMZ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-05-01",
        "reason": "GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury."
      },
      {
        "resNumber": "Z-2476-2026",
        "productCode": "FMZ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-05-01",
        "reason": "GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury."
      }
    ]
  },
  "registration": {
    "sites": 3,
    "countries": [
      "US"
    ]
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    {
      "code": "LNH",
      "deviceName": "System, Nuclear Magnetic Resonance Imaging",
      "clearances": 81,
      "latest": "2026-02-06",
      "medianReviewDays": 79
    },
    {
      "code": "JAK",
      "deviceName": "System, X-Ray, Tomography, Computed",
      "clearances": 68,
      "latest": "2026-06-24",
      "medianReviewDays": 45
    },
    {
      "code": "KPS",
      "deviceName": "System, Tomography, Computed, Emission",
      "clearances": 27,
      "latest": "2021-08-20",
      "medianReviewDays": 84
    },
    {
      "code": "LLZ",
      "deviceName": "System, Image Processing, Radiological",
      "clearances": 19,
      "latest": "2015-07-29",
      "medianReviewDays": 76
    },
    {
      "code": "MOS",
      "deviceName": "Coil, Magnetic Resonance, Specialty",
      "clearances": 19,
      "latest": "2011-04-01",
      "medianReviewDays": 65
    },
    {
      "code": "IYN",
      "deviceName": "System, Imaging, Pulsed Doppler, Ultrasonic",
      "clearances": 12,
      "latest": "2022-06-27",
      "medianReviewDays": 29
    },
    {
      "code": "IYO",
      "deviceName": "System, Imaging, Pulsed Echo, Ultrasonic",
      "clearances": 11,
      "latest": "2000-04-19",
      "medianReviewDays": 56
    },
    {
      "code": "OWB",
      "deviceName": "Interventional Fluoroscopic X-Ray System",
      "clearances": 11,
      "latest": "2006-06-07",
      "medianReviewDays": 42
    },
    {
      "code": "IZI",
      "deviceName": "System, X-Ray, Angiographic",
      "clearances": 10,
      "latest": "1998-02-13",
      "medianReviewDays": 85
    },
    {
      "code": "KPR",
      "deviceName": "System, X-Ray, Stationary",
      "clearances": 9,
      "latest": "2011-08-12",
      "medianReviewDays": 27
    },
    {
      "code": "IZL",
      "deviceName": "System, X-Ray, Mobile",
      "clearances": 8,
      "latest": "2021-04-28",
      "medianReviewDays": 30
    },
    {
      "code": "FRG",
      "deviceName": "Wrap, Sterilization",
      "clearances": 4,
      "latest": "1996-02-27",
      "medianReviewDays": 36
    },
    {
      "code": "IZO",
      "deviceName": "Generator, High-Voltage, X-Ray, Diagnostic",
      "clearances": 4,
      "latest": "1995-11-24",
      "medianReviewDays": 31
    },
    {
      "code": "LNI",
      "deviceName": "System, Nuclear Magnetic Resonance Spectroscopic",
      "clearances": 4,
      "latest": "2001-08-22",
      "medianReviewDays": 58
    },
    {
      "code": "DWS",
      "deviceName": "Instruments, Surgical, Cardiovascular",
      "clearances": 3,
      "latest": "1996-04-19",
      "medianReviewDays": 90
    },
    {
      "code": "IZH",
      "deviceName": "System, X-Ray, Mammographic",
      "clearances": 3,
      "latest": "2004-04-19",
      "medianReviewDays": 198
    },
    {
      "code": "OUO",
      "deviceName": "Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance",
      "clearances": 3,
      "latest": "2022-01-20",
      "medianReviewDays": 57
    },
    {
      "code": "ITX",
      "deviceName": "Transducer, Ultrasonic, Diagnostic",
      "clearances": 2,
      "latest": "2000-04-24",
      "medianReviewDays": 26
    },
    {
      "code": "IXL",
      "deviceName": "Device, Spot-Film",
      "clearances": 2,
      "latest": "2011-07-19",
      "medianReviewDays": 13
    },
    {
      "code": "IXR",
      "deviceName": "Table, Radiographic, Tilting",
      "clearances": 2,
      "latest": "1997-10-16",
      "medianReviewDays": 49
    },
    {
      "code": "IYX",
      "deviceName": "Camera, Scintillation (Gamma)",
      "clearances": 2,
      "latest": "1993-08-05",
      "medianReviewDays": 49
    },
    {
      "code": "IZF",
      "deviceName": "System, X-Ray, Tomographic",
      "clearances": 2,
      "latest": "2013-11-18",
      "medianReviewDays": 59
    },
    {
      "code": "JAA",
      "deviceName": "System, X-Ray, Fluoroscopic, Image-Intensified",
      "clearances": 2,
      "latest": "2006-06-07",
      "medianReviewDays": 14
    },
    {
      "code": "MQB",
      "deviceName": "Solid State X-Ray Imager (Flat Panel/Digital Imager)",
      "clearances": 2,
      "latest": "2010-11-18",
      "medianReviewDays": 70
    },
    {
      "code": "OXO",
      "deviceName": "Image-Intensified Fluoroscopic X-Ray System, Mobile",
      "clearances": 2,
      "latest": "1998-04-24",
      "medianReviewDays": 41
    }
  ],
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  "productCodesTotal": "40",
  "recentClearances": [
    {
      "kNumber": "K253560",
      "deviceName": "Enhanced Boundary for PCCT",
      "productCode": "JAK",
      "decisionDate": "2026-06-24",
      "reviewDays": 219
    },
    {
      "kNumber": "K253502",
      "deviceName": "Critical Care Suite with Enteric Tube Positioning AI Algorithm",
      "productCode": "QIH",
      "decisionDate": "2026-04-14",
      "reviewDays": 166
    },
    {
      "kNumber": "K253520",
      "deviceName": "Photonova Spectra, Photonova Spectra Select",
      "productCode": "JAK",
      "decisionDate": "2026-03-20",
      "reviewDays": 128
    },
    {
      "kNumber": "K253780",
      "deviceName": "SIGNA™ Bolt",
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      "decisionDate": "2026-02-06",
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    },
    {
      "kNumber": "K253779",
      "deviceName": "SIGNA™ Sprint Select",
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      "deviceName": "AIR Recon DL",
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      "kNumber": "K251399",
      "deviceName": "SIGNA™ Sprint",
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    {
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}