{
  "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,
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  "results": [
    {
      "cfres_id": "203648",
      "product_res_number": "Z-0324-2024",
      "event_date_initiated": "2023-09-01",
      "event_date_posted": "2023-11-17",
      "recall_status": "Open, Classified",
      "res_event_number": "93203",
      "product_code": "NVK",
      "k_numbers": [
        "K221761"
      ],
      "product_description": "Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal  CUS-00226 Rev. K reworked",
      "code_info": "Solea Model 3.0: UDI-DI: 00850634007018;\nSerial Numbers: 0310516, 0310517, 0310518, 0310519, 0310520, 0310521, 0310522, 0310523, 0310524, 0310525, 0310526, 0310527, 0310528, 0310529, 0310530, 0310531, 0310532, 0310533, 0310534, 0310535, 0310536, 0310537, 0310538, 0310539, 0310540, 0310541, 0310542, 0310543, 0310317, 0310321, 0310322, 0300730;\n\nSolea Model 2.0: UDI-DI: 00850634007001;\nSerial Numbers: 0200822, 0200807, 0200810, 0200625, CDS2-U33W-1B-DE-15, 0200819, 0200401",
      "firm_fei_number": "3010175098",
      "recalling_firm": "Convergent Dental",
      "address_1": "140 Kendrick St Bldg C3 140 Kendrick St",
      "address_2": "Bldg C3",
      "city": "Needham",
      "state": "MA",
      "postal_code": "02494-2739",
      "additional_info_contact": "Customer Support\n508-500-5670",
      "reason_for_recall": "It has been found that potential unintended laser activation can occur without foot pedal depression.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An URGENT: MEDICAL DEVICE RECALL notification letter dated 9/1/23 was sent to customers.\n\nPlease discontinue use of this product until your replacement foot pedal arrives.\n\nA replacement foot pedal (part number CUS-00226 Rev Q) will be shipped to the address that we have on file for your office and should arrive no later than September 6, 2023. Your shipment tracking number is [Insert]. A return shipping label will be included in the package. Please send back your original foot pedal for inspection and monitored disposal. Connecting the replacement foot pedal will resolve this issue with no further action required.\n\nThe part number and sub part number can be found at the bottom of your Solea foot pedal as shown in the attached photo. If the part number, sub-part number, and revision number do not match the recalled product, please call me directly at 617-480-3213.\nConvergent Dental is committed to product quality as well as patient and user safety. If you have any questions about this recall, please contact our Customer Support line at 508-500-5670.\n\nAn Acknowledgement and Receipt Form is attached. Please complete the form and return it to Convergent Dental.\n\nAn amended URGENT: MEDICAL DEVICE RECALL was sent to customers on 9/5/23.  \n\nProtective eyewear must be worn by everyone who is in the operating environment while the laser is turned on (Armed State). Periodically inspect protective eyewear (laser safety glasses) for pitting and cracking. Please be warned that failure to follow these measures may lead to ocular damage.",
      "product_quantity": "39 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AK, AL, CA, CT, FL, KY, ME, MI, MO, MT, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI and the country of Canada.",
      "openfda": {
        "k_number": [
          "K243764",
          "K210350",
          "K214008",
          "K213428",
          "K250731",
          "K201387",
          "K221761",
          "K211150",
          "K030146",
          "K203396",
          "K232222",
          "K230047",
          "K253309",
          "K260765",
          "K213658",
          "K210367",
          "K232885"
        ],
        "device_name": "Laser, Dental, Soft Tissue",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4810",
        "device_class": "2",
        "registration_number": [
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