{
  "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": "196320",
      "product_res_number": "Z-0168-2023",
      "event_date_initiated": "2022-10-03",
      "event_date_posted": "2022-11-01",
      "recall_status": "Open, Classified",
      "res_event_number": "90968",
      "product_code": "PMW",
      "product_description": "Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light.\nModel Number BQ830",
      "code_info": "UDI: 008648160004\n\nSerial Numbers:\nB-00001-V thru B-00105-V\nB-00021\nB-00022\nB-00036\nB-00052\nB-00054 thru B-00060\nB-00062 thru B-00065\nB-00070\nB-00071\nB-00075 thru B-00077\nB-00079\nB-00082 thru B-00098\nB-00100 thru B-00104\nB-00106\nB-00109\nB-00111 thru B-00113",
      "firm_fei_number": "3014522421",
      "recalling_firm": "Rebiscan, Inc.",
      "address_1": "100 Cambridge St Fl 14 100 Cambridge St",
      "address_2": "Fl 14",
      "city": "Boston",
      "state": "MA",
      "postal_code": "02114-2509",
      "additional_info_contact": "SAME\n857-600-0982",
      "reason_for_recall": "Unable to charge the battery pack- battery packs will allow the batteries to be charged if the voltage of any cell is below 2.5V. When this occurs, the battery\npack will not accept the charge, could vent and possibly catch fire",
      "root_cause_description": "Device Design",
      "action": "Rebion issued Urgent Medical Device Removal letter on 10/3/22 via Certified Mail.\nLetter states reason for recall, health risk and action to take:\n1. Return the provided response form acknowledge receipt of this communication.\n2. Stop using the device\n3. Return the device, along with its power cord and carry case, to Rebion\nIn the event that you have noticed abnormal device behavior related to charging,\nbattery life, or excessive heat while operating the device, then please contact us\nimmediately\nPLANNED ACTION TO BE TAKEN BY REBION\n1. Rebion plans to evaluate and repair each device at no charge.\n2. Provide each customer with a postage paid shipping label\n3. Upon receipt of the device, Rebion will determine whether the battery pack is\naffected.\n4. Affected battery packs will be replaced.\n5. The device will be returned to the customer.\nFURTHER INFORMATION AND SUPPORT\nIf you need further information or support for this issue, contact your Rebion\nrepresentative or contact Rebion Customer Service at 877-499-9966.",
      "product_quantity": "63 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of New Zealand, Belgium.",
      "openfda": {
        "k_number": [
          "DEN130051"
        ],
        "registration_number": [
          "3012983142",
          "3014522421"
        ],
        "fei_number": [
          "3012983142",
          "3014522421"
        ],
        "device_name": "Strabismus Detection Device",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.1342",
        "device_class": "2"
      }
    }
  ]
}