{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "215957",
      "product_res_number": "Z-0460-2026",
      "event_date_initiated": "2025-08-22",
      "event_date_posted": "2025-11-07",
      "recall_status": "Open, Classified",
      "res_event_number": "97568",
      "product_code": "IXR",
      "product_description": "Brand Name: Sonesta\nProduct Name: 6210\nModel/Catalog Number: 0120-LA120-03\nSoftware Version: N/A\nProduct Description: Sonesta 6210 - Procedure table designed for full fluoroscopic imaging of the urinary tract during video Urodynamics procedures.\nComponent: N/A",
      "code_info": "Lot Code: Primary DI Number: 07350006950018\n\nSerial numbers of potentially affected units:\n12-70791\n12-70792\n12-70793\n12-70794\n12-70795\n12-70796\n12-70797\n12-70798\n12-70799\n12-70801",
      "firm_fei_number": "3010496070",
      "recalling_firm": "Sonesta Medical AB",
      "address_1": "Industrivagen 7 7 industrivagen",
      "city": "Solna",
      "country": "Sweden",
      "additional_info_contact": "Pelin Sari\n46812876608",
      "reason_for_recall": "Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.",
      "root_cause_description": "Process control",
      "action": "On September 8, 2025, Sonesta Medical AB issued a recall notification to affected consignees via E-Mail.  Sonesta asked consignees to take the following actions:\n\n1. Please review your table and confirm that the serial number on the product labeling matches with the number listed in the notification.\n2. Please discontinue use of the table.  It is recommended that you place a copy of this notice on the table to provide staff awareness of the issue.\n3. Sonesta will contact you to schedule and perform a table inspection as soon as possible.\n4. If the table inspection results are acceptable, Sonesta will provide you with evidence to continue to use the table.\n5. If the table inspection results are unacceptable, Sonesta and Laborie will work with you to replace your table\n\nIf you have any questions, contact the CEO via email: Pelin.Sari@sonestamedical.se or phone +468-502 572 80.",
      "product_quantity": "10 tables",
      "distribution_pattern": "US Distribution to NH only.",
      "openfda": {
        "k_number": [
          "K922591",
          "K771293",
          "K950981",
          "K911267",
          "K896119",
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          "K874113",
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          "K954356",
          "K882019",
          "K843926",
          "K883863",
          "K903422",
          "K951176",
          "K944987",
          "K931563",
          "K945842",
          "K792326",
          "K905153",
          "K912586",
          "K970640",
          "K953556",
          "K915853",
          "K854486",
          "K913147",
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          "K883153",
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          "K860913",
          "K910838",
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          "K961022",
          "K896324",
          "K854085",
          "K905152",
          "K912741",
          "K920728",
          "K924326",
          "K940721",
          "K925175",
          "K792645",
          "K883162",
          "K896583",
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          "K901654",
          "K973039",
          "K854478",
          "K781532",
          "K911098",
          "K950402"
        ],
        "registration_number": [
          "3015276088",
          "3010496070",
          "9616014",
          "2243057",
          "3033525986",
          "8030233",
          "3004977335",
          "3013846070",
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          "3007912863",
          "2529571",
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          "3009077524",
          "1225473",
          "3002808176",
          "3000126629",
          "3026048448",
          "9610903",
          "3003768251",
          "3008284470",
          "9613445",
          "3003927316",
          "3033527770"
        ],
        "fei_number": [
          "3015276088",
          "3002675731",
          "3002808139",
          "3010496070",
          "1000121370",
          "2243057",
          "3033525986",
          "3004977335",
          "3001237319",
          "3013846070",
          "3007912863",
          "3003434037",
          "3009077524",
          "3002808176",
          "3000126629",
          "3026048448",
          "3003768251",
          "3008284470",
          "3002175190",
          "3002807145",
          "3003927316",
          "1000305755",
          "3033527770"
        ],
        "device_name": "Table, Radiographic, Tilting",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1980",
        "device_class": "2"
      }
    }
  ]
}