{
  "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": "36615",
      "product_res_number": "Z-0422-05",
      "event_date_initiated": "2005-01-07",
      "event_date_posted": "2005-01-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-01-17",
      "res_event_number": "30797",
      "product_code": "DXJ",
      "k_numbers": [
        "K932724"
      ],
      "product_description": "Ultraview Universal Clinical Workstation System Model 90385.",
      "code_info": "Universal Ultraview Clinical Workstation Model 90385 base versions with Revision M or earlier.  This recall involves certain units within the serial number range SN: 385-000337 to SN: 385-111440.  The firm indicated that not all serial numbers within this range are affected by this recall, but only those units with the specified Revision M or earlier base which have not already been updated.",
      "firm_fei_number": "3010157426",
      "recalling_firm": "Spacelabs Medical Incorporated",
      "address_1": "5150 220th Ave Se",
      "city": "Issaquah",
      "state": "WA",
      "postal_code": "98029-6834",
      "additional_info_contact": "Al Van Houdt\n425-657-7200 Ext. 5970",
      "reason_for_recall": "Weakness of the swivel base for the universal clinical workstation  may result in the unit falling from its mounted position endangering users and patients.",
      "root_cause_description": "Other",
      "action": "All US customers were sent a Medical Device Recall letter on 1/7/2005 describing how to examine monitors for the defect and to discontinue use of any suspect unit s until examintaion by a Field Service Engineer .  International customers will be notified via email or letter on 1/14/2005.  Follow up contact by Customer Support and Global Support is planned for any customer not responding with a FAX-back form.",
      "product_quantity": "12,306 devices with this base style.",
      "distribution_pattern": "The firm completed a survey of their customer records and determined a total of 12,306 units were installed from January of 1994 through December of 1997.  7,601 units were originally sold to 767 US accounts and 4,705 units were sold to 102 international accounts.  The firm estimates approximately 3000 units worldwide are still in operation with the Revision M or earlier base.",
      "openfda": {
        "k_number": [
          "K053356",
          "K810164",
          "K760721",
          "K173107",
          "K926219",
          "K810168",
          "K831781",
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          "K201162",
          "K945277",
          "K103473",
          "K901072",
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        ],
        "registration_number": [
          "9613188",
          "8043933",
          "9610816",
          "3010698831",
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          "3002579136",
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          "3011050570",
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          "1218950",
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          "1651104",
          "3010331645",
          "3020704423",
          "1220246",
          "9611109",
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        ],
        "fei_number": [
          "3010698831",
          "1220908",
          "3016851379",
          "3008483389",
          "3019269298",
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          "3002807798",
          "3010331645",
          "3020704423",
          "3002807167",
          "1220246",
          "3006615345"
        ],
        "device_name": "Display, Cathode-Ray Tube, Medical",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.2450",
        "device_class": "2"
      }
    }
  ]
}