{
  "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": "2026-09-17",
    "results": {
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  "results": [
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      "product_res_number": "Z-0998-2026",
      "event_date_initiated": "2025-08-27",
      "event_date_posted": "2026-01-07",
      "recall_status": "Open, Classified",
      "res_event_number": "98236",
      "product_code": "IWE",
      "product_description": "The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.",
      "code_info": "Part Number V000629",
      "firm_fei_number": "3004832819",
      "recalling_firm": "Vision RT Ltd",
      "address_1": "Dove House Arcadia Avenue",
      "city": "London",
      "country": "United Kingdom",
      "reason_for_recall": "Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).",
      "root_cause_description": "Radiation Control for Health and Safety Act",
      "action": "Vision RT wrote to inform customers of an omission that they have identified in the Instructions for Use for AlignRT InBore systems. This notification contained information for users of AlignRT InBore systems on the content omitted and how to access the corrected Instructions for Use.",
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