{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Blaine",
      "address_1": "10675 Naples St NE",
      "reason_for_recall": "If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the implantable pulse generator (lPG). This may result in the user being unable to recharge the lPG.  This safety notice only applies to CPs Model 4500.",
      "address_2": "",
      "product_quantity": "17 OUS",
      "code_info": "Serial  000010  000011  FF0043  FF0045  000014  000015  000016  FF0054  FF0048  FF004B  FF005D  FF0064  FF0065  FF0067  FF00A9  FF00AD  FF00BB      Lot   P178713  P185700  P187989  P195875  P213108  P257056",
      "center_classification_date": "20160503",
      "distribution_pattern": "Germany",
      "state": "MN",
      "product_description": "Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems.  The version of the software in the Clinician Programmer is v1.1.5.     The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient¿¿\"s spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patient¿¿\"s brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patient¿¿\"s use of the system.     The Clinician Programmer (CP) is a hand-held, touch screen device used to create and adjust stimulation parameters that are developed to optimize the therapy for each patient. The CP communicates with the stimulator via the Medical Implant Communication Service (MICS). The CP wirelessly transfers the stimulation parameters to the stimulator.  In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs and IPGs",
      "report_date": "20160511",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Nuvectra",
      "recall_number": "Z-1600-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "73884",
      "termination_date": "20170929",
      "more_code_info": "",
      "recall_initiation_date": "20160406",
      "postal_code": "55449-5802",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}