{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "94636",
      "product_res_number": "Z-0611-2011",
      "event_date_initiated": "2010-09-09",
      "event_date_posted": "2010-12-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-03-21",
      "res_event_number": "56849",
      "product_code": "IKZ",
      "product_description": "RotoProne Therapy System, Model 209500, Device List Number E232632\nProduct is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It is intended for the treatment and prevention of pulmonary complications associated with immobility.",
      "code_info": "Serial number ranges:  RRFK00036-RRFK00047; RRFK00049-RRFK00115;  RRFK00117-RRFK00128; RRFK00141-RRFK00211;  RRFK00213-RRFK00233; RRFK00235;  RRFK00237-RRFK00254;  RRFK00256-RRFK00270;  RRFK00273-RRFK00280;  RRFK00282-RRFK00284;  RRFK00287-RRFK00290;  RRJK0001; RRIK00003; RRIK00004; RRFK00234; RRFK00236; RRFK00285;  RRFK00286; and RRJK00002",
      "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": "210-255-5571",
      "reason_for_recall": "Product complaints indicating that while attempting to resolve an alarm or error condition, operator was unable to return product to the prone position for patient.",
      "root_cause_description": "Other",
      "action": "KCI USA, Inc. sent an URGENT - Medical Device Safety Alert letter, dated September 8, 2010, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the cusotmer.  Customers were instructed to have a practiced back-up plan, such as a plan for the manual proning of patients in the event that clinical circumstances dictate the need for more immediate prone therapy.  \nFor questions, customers in the US should call KCI's Technical Support Center at 1-800-275-4524, option 5.  For  customers outside the US they should contact their local sales representative.  \nCustomers should contact their accounts with affected product and advise them of the safety notice.",
      "product_quantity": "240 units",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide, United Kingdom, Germany, and Saudi Arabia",
      "openfda": {
        "k_number": [
          "K954671",
          "K810220",
          "K972111",
          "K822402",
          "K905390",
          "K933964",
          "K922473",
          "K842604",
          "K923710",
          "K950756",
          "K950681",
          "K972486",
          "K823095",
          "K873047",
          "K834563",
          "K962788",
          "K905113"
        ],
        "device_name": "Bed, Patient Rotation, Powered",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.5225",
        "device_class": "2",
        "registration_number": [
          "8044130",
          "3013846070",
          "3038008630",
          "3007420694",
          "3018115441",
          "3002798200",
          "3006891315",
          "3016947689",
          "1043644",
          "3030492371",
          "3009591865",
          "1831750",
          "3015423385",
          "3040337865",
          "2030732",
          "3005179379",
          "1954156",
          "9681684",
          "1931307",
          "2032121"
        ],
        "fei_number": [
          "3002655016",
          "3013846070",
          "3038008630",
          "3018115441",
          "3002693132",
          "3003083675",
          "3002798200",
          "3006891315",
          "3016947689",
          "1043644",
          "3030492371",
          "3009591865",
          "1831750",
          "3015423385",
          "3040337865",
          "3005743621",
          "3005179379",
          "3000204953",
          "1931307",
          "3007420694"
        ]
      }
    }
  ]
}