{
  "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": {
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  "results": [
    {
      "cfres_id": "34983",
      "product_res_number": "Z-0186-05",
      "event_date_initiated": "2004-09-15",
      "event_date_posted": "2004-11-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-02-15",
      "res_event_number": "29999",
      "product_code": "GWE",
      "k_numbers": [
        "K880773"
      ],
      "product_description": "The Enfant Evoked Response Photic Stimulator.  The Enfant A Pediatric Vision Testing Device, Manufactured by Diopsys, Inc., 355 Main St., Metuchen, NJ  08840.  Each medical device unit is assembled and contains an 18 inch flat panel vision stimulator panel, a 17 inch flat panel operator monitor, a 2.25 inch thermal printer, a mobile point of care cart, medical grade battery back-up, speaker, a CPU with floppy and CD drives, a camera and an isolation transformer.",
      "code_info": "No manufacturing codes are affixed to the units.  The firm maintains some in-house identification numbers which are: 10001; 10003; 10004; 10005; 10006; 10007; 10008; 10009; 100010; 100011; 100012; 100013; 100014; 100015; 100016.",
      "firm_fei_number": "3004174467",
      "recalling_firm": "Diopsys Inc",
      "address_1": "355 Main St",
      "city": "Metuchen",
      "state": "NJ",
      "postal_code": "08840",
      "additional_info_contact": "Joseph A. Fontanetta\n732-321-6566 Ext. 11",
      "reason_for_recall": "The firm established no medical device quality system, no established quality plan and no established quality procedures.",
      "root_cause_description": "Other",
      "action": "The firm sent out a recall letter to their customers on 09/14/2004 stating that a field correction will be conducted at each site.",
      "product_quantity": "18 units",
      "distribution_pattern": "The firm distributes the Enfant VEP medical device systems in 3 states, NY, NJ, and CT at the current time. There is no international distribution at this time.  There are no Government, or military accounts.  The rental/leasing of the units are direct.  No contracts have been established.  There are 17 domestic consignees.",
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        "device_name": "Stimulator, Photic, Evoked Response",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.1890",
        "device_class": "2"
      }
    }
  ]
}