{
  "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": "86580",
      "product_res_number": "Z-0566-2010",
      "event_date_initiated": "2009-11-03",
      "event_date_posted": "2009-12-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-12-10",
      "res_event_number": "53817",
      "product_code": "MMZ",
      "product_description": "Stille Sonesta Gynecology and Urology Table 6303 ; an electric cystometric table; Stille AB, Solna, Sweden.\n\nUsed to position the subject/patient in a desired position during urodynamic, general examinations, cystoscopy, ultrasound, biofeedback, vasectomy and OBGYN procedures.",
      "code_info": "Model 6303, serial numbers 12-11076, 12-11077, 12-11078, 12-11079, 12-11080, 12-11081, 12-11082, 12-11083, 12-11084, 12-11086, 12-11127, 12-11129, 12-11133, 12-11134, 12-11137, 12-11141, 12-11145, 12-11273, 12-11274; tables sold between 3/24/09 and 9/30/09",
      "firm_fei_number": "3003696170",
      "recalling_firm": "Stille AB",
      "address_1": "Gardsvagen 14 14 gardsvagen",
      "city": "Solna",
      "country": "Sweden",
      "additional_info_contact": "800-655-1614",
      "reason_for_recall": "There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Stille sent Field Safety Notices dated 10/30/09 to the direct accounts, informing them that there is a potential hazard with the Sonesta tables if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure. Stille developed a retrofit kit consisting of six side rail bolts and instructions for installing the bolts, which were sent to the end users with the safety notice.  The accounts were requested to replace the side rail bolts with the new bolts provided, and to complete and return the enclosed acknowledgement card to Stille by fax or e-mail as soon as possible and no later than 12/11/09. Contact Stille Surgical Inc. at 224-612-5404 for assistance.",
      "product_quantity": "68 units total",
      "distribution_pattern": "Worldwide Distribution -- Including countries of USA and Canada.",
      "openfda": {
        "registration_number": [
          "1054241",
          "9612448",
          "3029906632",
          "2182318",
          "3031564213",
          "1223864",
          "3002808176",
          "2243057",
          "1055236",
          "2529571",
          "1721686",
          "3010193531",
          "3017636737",
          "1043214",
          "1825014",
          "3010496070"
        ],
        "fei_number": [
          "1000305755",
          "3002806876",
          "3029906632",
          "2182318",
          "3031564213",
          "3002808176",
          "2243057",
          "1000112877",
          "1043214",
          "1721686",
          "3010193531",
          "3017636737",
          "1000121370",
          "1825014",
          "1000112968",
          "3010496070"
        ],
        "k_number": [
          "K033335",
          "K942485",
          "K954278",
          "K942445"
        ],
        "device_name": "Table, Cystometric, Electric",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4890",
        "device_class": "2"
      }
    }
  ]
}