{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "29343",
      "product_res_number": "Z-0047-04",
      "event_date_initiated": "2003-08-19",
      "event_date_posted": "2003-10-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-03-22",
      "res_event_number": "27169",
      "product_code": "LMB",
      "k_numbers": [
        "K934888",
        "K934889"
      ],
      "product_description": "Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8)  \nCommon name: Medical image storage device.  Class I, 510 (k) exempt.  (NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking. It is a condition of the software malfunction that the observed image crosslink results from the collision of data files from two separate ImageManager computers.)",
      "code_info": "Versions 6.0 through 6.4.1 (excluding version 6.3.8)",
      "firm_fei_number": "2429304",
      "recalling_firm": "Olympus America Inc.",
      "address_1": "Two Corporate Center Drive",
      "city": "Melville",
      "state": "NY",
      "postal_code": "11747",
      "additional_info_contact": "Laura  Storms-Tyler\n631-844-5688",
      "reason_for_recall": "Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.",
      "root_cause_description": "Other",
      "action": "OAI sent \"Urgent-Device Correction\" letters, dated 8/19/03, to the end users, explaining the software malfunction.  The letter also provided specific instructions to the end users until the software fix is installed.  For technical assistance, users can contact OAI's Technical Assistance Center 1-800-848-9024.  Accompanying the letter is a questionnaire to be completed by the end users & returned to OAI for scheduling an appointment to visit the facility to install the software fix.",
      "product_quantity": "1014",
      "distribution_pattern": "Medical facilities (end users) nationwide and Puerto Rico, plus 5 foreign accounts located in Canada, Mexico, Ecuador and Chile.",
      "openfda": {
        "k_number": [
          "K980243",
          "K891690",
          "K903806",
          "K955237",
          "K961680",
          "K984405",
          "K915094",
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          "K950630",
          "K905488",
          "K884990",
          "K983447",
          "K844132",
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          "K901956",
          "K973413",
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          "K964803",
          "K933115",
          "K960941",
          "K950279",
          "K921275",
          "K931410",
          "K914728",
          "K934888",
          "K973463",
          "K901118",
          "K963395",
          "K961160",
          "K971848",
          "K945654",
          "K863286"
        ],
        "registration_number": [
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          "3007457520",
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        "fei_number": [
          "3021023132",
          "3014232530",
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          "3043648115",
          "3010583458",
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          "3005205318",
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          "3016527960",
          "1000181430",
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          "3001451602",
          "3014991167",
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          "3004722076",
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          "3007137598",
          "3010862763",
          "3010326005",
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          "3001452787",
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        ],
        "device_name": "Device, Digital Image Storage, Radiological",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.2010",
        "device_class": "1"
      }
    }
  ]
}