{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "111749",
      "product_res_number": "Z-0409-2013",
      "event_date_initiated": "2012-06-27",
      "event_date_posted": "2012-11-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-04-22",
      "res_event_number": "62805",
      "product_code": "IOQ",
      "product_description": "RotoRest Delta Kinetic Therapy System\n\nINDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction",
      "code_info": "Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.",
      "firm_fei_number": "1625774",
      "recalling_firm": "KCI USA, Inc.",
      "address_1": "4958 Stout Dr",
      "city": "San Antonio",
      "state": "TX",
      "postal_code": "78219-4334",
      "additional_info_contact": "KCI's Customer Technical Service Center\n800-275-4524",
      "reason_for_recall": "The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack.  KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack.  In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.",
      "root_cause_description": "Component design/selection",
      "action": "KCI sent an Urgent - Voluntary Medical Device Correction letter dated June 27, 2012, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed that KCI would contact them soon to coorinate a shipment of a replacement of the affected product.  For any questions customers were instructed to call 1-800-275-4524, Selection Option 3 followed by Option 2.\nFor questions regarding this recall call 1-800-275-4524.",
      "product_quantity": "282 units",
      "distribution_pattern": "Nationwide Distribution including AL, CA, CO, OK and GA.",
      "openfda": {
        "k_number": [
          "K910851",
          "K970295",
          "K893801",
          "K894723",
          "K914674",
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          "K832829",
          "K923977",
          "K882607",
          "K926456",
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          "K922140",
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          "K943433",
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          "K970363",
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          "K863047",
          "K970364",
          "K951001",
          "K840881",
          "K840697",
          "K905126",
          "K893614",
          "K880486",
          "K931594",
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          "K901295",
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          "K901890",
          "K922973",
          "K940662",
          "K894353",
          "K143414",
          "K973624"
        ],
        "registration_number": [
          "3012292104",
          "2030732",
          "9710603",
          "8043439",
          "3006697241",
          "3031218453",
          "3007309299",
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          "3010010434",
          "8022290",
          "3011489684",
          "2030595",
          "1931307",
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        ],
        "fei_number": [
          "3004411059",
          "3012292104",
          "3006697241",
          "3031218453",
          "3007309299",
          "1000518730",
          "3002693132",
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          "3003513125",
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          "3010010434",
          "3011489684",
          "3003083675",
          "1931307",
          "1000220700",
          "3036779619"
        ],
        "device_name": "Bed, Flotation Therapy, Powered",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.5170",
        "device_class": "2"
      }
    }
  ]
}