{
  "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": "183814",
      "product_res_number": "Z-0091-2021",
      "event_date_initiated": "2019-10-14",
      "event_date_created": "2020-10-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-09-27",
      "res_event_number": "86482",
      "product_code": "JEA",
      "product_description": "Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI\n\nRefurbished Levo Arm Label: LEVO ARM REF 7887-050R\nMIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.",
      "code_info": "Model Number: 7887-050 UDI/GTIN 00842230104992 Affected Serial Numbers: 201 through 452  Model 7887-050R UDI/GTIN 00824230108440 Affected Serial Numbers: 234, 235, 248, 255, 341, and 448",
      "firm_fei_number": "2921578",
      "recalling_firm": "Mizuho OSI",
      "address_1": "30031 Ahern Ave",
      "city": "Union City",
      "state": "CA",
      "postal_code": "94587-1234",
      "additional_info_contact": "Anne LeBlanc\n800-777-4674",
      "reason_for_recall": "Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and lead to a failure of the locking mechanism",
      "root_cause_description": "Device Design",
      "action": "On 10/14/2019, the firm sent an \"URGENT: Medical Device Recall\" notification to customers via courier (e.g., UPS or FedEx) and an email to distributors informing them that they have become aware of the potential for fluid ingress rendering the internal electronics inoperable and leading to a failure of the Arm's locking mechanism.  The Recalling Firm is instructing customers that they can continue to use the Arm until a replacement Arm is provided, but if either of the following scenarios apply to the devices, to please cease uses immediately and contact the Recalling Firm's Service Department.  The two scenarios are:\n-The customer believes the Arm has been exposed to excessive fluids at any point while in use;\n-The customer notices any slipping of the Arm while properly installed for its intended use.\n\nCustomers are asked to refer to the Owner's Manual for specific instructions on how to properly clean all modules of the Head Positioning System, including the Arm.  Instructions are found in Section 13 of the manual.  In addition, the cleaning instructions are included within the Customer Notification Letter.\n\nThe Recalling Firm is proactively replacing Arms.  Customer should follow the instruction regarding the Exchange Program:\n-Recalling Firm will provide a replacement Arm at no charge.  The timing of the replacement will be based upon product availability and is expected to be completed within 16 weeks.\n-The Recalling Firm's Sales or Service members will assist customers with the packaging and return of the existing Arm(s) upon the receipt of the upgraded model.\n\nCustomers are also asked to respond to the Customer Notification Letter by:\n1. Confirm receipt and understanding of the notice by signing and returning the response portion of the Notification letter to the Recalling Firm's Regulatory Department at: FAX Number +1-510-429-9945 or email notice@mizuhosi.com\n2. Any questions about the exchange plan, call the Recalling Firm's Service Department a",
      "product_quantity": "174 Arms",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution including in   states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, SC, TN, TX, VA, WI, and WV.\n\nThe countries of Australia, Belgium, Canada, Columbia, Germany, Israel, South Korea, New Zealand, Poland, United Kingdom, and South Africa.",
      "openfda": {
        "device_name": "Table, Surgical With Orthopedic Accessories, Ac-Powered",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4960",
        "device_class": "1",
        "registration_number": [
          "3007031002",
          "2916273",
          "2221819",
          "8043933",
          "3013522950",
          "9680168",
          "3027847726",
          "1066635",
          "3013836619",
          "8010652",
          "3012995405",
          "3003923584",
          "3043007473",
          "3031563141",
          "2921578",
          "1043572",
          "3015223105",
          "1000351276",
          "3010890274",
          "3009760038",
          "3012329926",
          "9681642",
          "3011111237",
          "3007143268"
        ],
        "fei_number": [
          "3007031002",
          "1000395711",
          "2916273",
          "2221819",
          "3013522950",
          "1000295034",
          "3002619595",
          "1841",
          "3027847726",
          "3013836619",
          "3003184737",
          "3012995405",
          "3003923584",
          "3043007473",
          "3031563141",
          "2921578",
          "1043572",
          "3015223105",
          "1000351276",
          "3010890274",
          "3009760038",
          "3012329926",
          "3011111237",
          "3007143268"
        ],
        "k_number": [
          "K900290",
          "K881060",
          "K911522",
          "K924094",
          "K873080",
          "K873079",
          "K910736",
          "K894789",
          "K874762",
          "K953071"
        ]
      }
    }
  ]
}