{
  "format": "devicerts.device.v1",
  "cite_as": "Mobilediagnost Wdr, Sedecal., Sa. deviCERTS medical device catalogue. https://devicerts.com/devices/mobilediagnost-wdr-izl (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/mobilediagnost-wdr-izl",
    "json_url": "https://devicerts.com/devices/mobilediagnost-wdr-izl.json",
    "markdown_url": "https://devicerts.com/devices/mobilediagnost-wdr-izl.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/mobilediagnost-wdr-izl",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Mobilediagnost Wdr",
    "registry_name": "MOBILEDIAGNOST WDR",
    "url": "https://devicerts.com/devices/mobilediagnost-wdr-izl",
    "manufacturer": {
      "name": "Sedecal., Sa.",
      "url": "https://devicerts.com/manufacturers/sedecal-sa",
      "country": null,
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K111725",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "IZL"
    ],
    "emdn": [],
    "gmdn": [],
    "description": null,
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K111725",
      "number_label": null,
      "device_udi_di": null,
      "date": "2011-07-19",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-0243-2026",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2025-06-10",
      "reason": "Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.",
      "applies": "this device",
      "via": "K111725"
    },
    {
      "number": "Z-1083-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2021-10-14",
      "reason": "While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button.  This would result in the system moving on its own in a very slow speed forward circular motion.",
      "applies": "this device",
      "via": "K111725"
    },
    {
      "number": "Z-1084-2016",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2016-01-18",
      "reason": "This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior.",
      "applies": "this device",
      "via": "K111725"
    },
    {
      "number": "Z-1691-2016",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2015-03-23",
      "reason": "Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type \" Newborn\" was selected and is displayed in the generator control area of the Eleva User Interface.",
      "applies": "this device",
      "via": "K111725"
    },
    {
      "number": "Z-1040-2015",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2014-08-06",
      "reason": "Reports of unexpected movement.",
      "applies": "this device",
      "via": "K111725"
    },
    {
      "number": "Z-0508-2015",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2014-04-08",
      "reason": "In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.",
      "applies": "this device",
      "via": "K111725"
    },
    {
      "number": "Z-1964-2013",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2013-06-11",
      "reason": "The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).",
      "applies": "this device",
      "via": "K111725"
    },
    {
      "number": "Z-1706-2017",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2012-11-28",
      "reason": "When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.",
      "applies": "this device",
      "via": "K111725"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
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            {
              "value": "K111725",
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                "FDA 510(k)"
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          ]
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            {
              "value": "IZL",
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            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
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            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.1720",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
              "registries": [
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            }
          ]
        },
        {
          "label": "FDA decision",
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            {
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          ]
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    }
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}