{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "202595",
      "product_res_number": "Z-0082-2024",
      "event_date_initiated": "2023-08-30",
      "event_date_posted": "2023-10-06",
      "recall_status": "Open, Classified",
      "res_event_number": "92789",
      "product_code": "OHV",
      "product_description": "CellQuicken Analyzer (Smart-Watch and Software),\nRoyalVibe Ultrasound Generator,\nBrainvibe,\nEnvirovibe Water Restructuring Pad,\nRoyalVibe Therapy Balls",
      "code_info": "CellQuicken Analyzer (Smart-Watch and Software), Software Version: 1,39. All distributed products manufactured between January 2020 and June 2022.",
      "firm_fei_number": "3022074304",
      "recalling_firm": "RoyalVibe Health Ltd.",
      "address_1": "1095 Evergreen Cir Ste 200 1095 Evergreen Cir",
      "address_2": "Ste 200",
      "city": "The Woodlands",
      "state": "TX",
      "postal_code": "77380-3646",
      "additional_info_contact": "Ryno van Tonder\n346-326-2866",
      "reason_for_recall": "Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. There is a possibility of customers' reliance on marketing claims which could cause the user to forgo medical treatment resulting in health consequences.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 8/30/23, customers were mailed recall notices and told to do the following:\n\nCease use and disconnect all cables. Please package securely in the return packaging provided and promptly return via parcel post, without discarding any part of it or accessories. Also, complete and return the Recall Return Response Form enclosed.\n\nCustomers with questions about this recall can call (832) 742 6292, Monday through Friday, between 9:00 AM and 4:00 PM, Central Time or email attorney@royalvibehealth.com.",
      "product_quantity": "564",
      "distribution_pattern": "US: MI, PA, TX, GA, OH, CA, FL, NY, NH, UT, AL, WA. WI, MN, MA, NM, IA, MD, IL, SC, NJ, NC, NV,  TN, AZ, OR, OK, LA, OR, NE, ME, CO, MS, MT, CT, KY, HI, IN, DC",
      "openfda": {
        "k_number": [
          "K230019",
          "K231537",
          "K191421",
          "K133238",
          "K240687",
          "DEN080006",
          "K223237",
          "K162163",
          "K161952",
          "K181896",
          "K141708",
          "K233996",
          "K232455",
          "K134032",
          "K100874",
          "K132028",
          "K122528",
          "K233104",
          "K260618",
          "K250418",
          "K160896",
          "K231628",
          "K180623",
          "K243035",
          "K230100",
          "K170370",
          "K230820",
          "K211483",
          "K121700",
          "K112626"
        ],
        "registration_number": [
          "3015889734",
          "3005646850",
          "1313525",
          "3033715699",
          "3013917867",
          "2030624",
          "3011423170",
          "3013840437",
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          "3027725665",
          "1725006",
          "3005238200",
          "3006807694",
          "3006985163",
          "3009736547",
          "2133641"
        ],
        "fei_number": [
          "3015889734",
          "3004106598",
          "3005646850",
          "3033715699",
          "3013917867",
          "3013840437",
          "3012259264",
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          "3000203466",
          "3003258642",
          "3005238200",
          "3006807694",
          "3006985163",
          "3009736547"
        ],
        "device_name": "Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4590",
        "device_class": "2"
      }
    }
  ]
}