{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Wayne",
      "address_1": "45 Barbour Pond Dr",
      "reason_for_recall": "The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.",
      "address_2": "",
      "product_quantity": "5214",
      "code_info": "Model VLT600 SF AIM STP:    Ref Code: ARD568811901:  Serial Numbers:   21001  21002  22000    Ref Code: ARD568811911:  Serial Numbers:  25002  31000  31001  31002  31003  31004  31006  31008  31009  31010  31012  31017  31018  31019  31020  31021  31022  31023  31024  31025  31026  35000  35001  35011  35012  35013  35014  35015  35017  35018  35019  35020  35021  35022  35023  35024  35025  35026  35027  35028  35029  35030  35031  35032  35033  38000  38001  38002  38003  38005  38009  38011  38012  38013  38014  38015  38016  38017  38018  38019  38020  38021  38022  38023  38024  38025  38026  38027  500000  500001  500002  500003  500004  500005    Model VLT600 DF AIM STP:    Ref Code: ARD568811951 (Not in distribution in the U.S.)  Serial Numbers:  20502  20503    Ref Code: ARD568811961  Serial Numbers:  25005  25006  25007  28003  28004  31000  31001  31002  31003  31004  31005  31006  31008  31009  31011  31012  31013  31014  31015  31016  31017  31019  31020  31030  31031  31039  31040  31041  31042  31043  31044  31045  31046  31047  31048  31049  31050  31051  31052  31053  31054  31055  31056  38025  38026  38027  38028  500001  500002",
      "center_classification_date": "20180410",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, ID, IA, KS, KY, ME, MO, NE, NY, OR, TN, TX, UT, and WA; and countries of: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cameroon, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Ghana, Hong Kong, Hungary, India, Iran, Iraq, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Poland, Portugal, South Korea, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad-Tobago, Turkey, UAE, UK, Yemen and Zimbabwe.",
      "state": "NJ",
      "product_description": "VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911  ARD568811951, ARD568811961    The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.",
      "report_date": "20180418",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "GETINGE US SALES LLC",
      "recall_number": "Z-1349-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79583",
      "termination_date": "20210902",
      "more_code_info": "",
      "recall_initiation_date": "20180207",
      "postal_code": "07470-2094",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}