{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Munich",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82601",
      "recalling_firm": "Brainlab AG",
      "address_1": "Olof-palme-str. 9",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KY, LA, MA, MD, MS, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, & WV.  Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, El Salvador, Finland, France, Germany, Hong Kong, Iran, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Martinique, Mexico, Monaco, Morocco, Netherlands, Poland, Portugal, Russian Fed., South Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, United Arab Emirates, and United Kingdom.",
      "recall_number": "Z-1205-2019",
      "product_description": "RT Elements   Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected:  -\tCranial SRS 1.0.0 and 1.5.0  -\tSpine SRS 1.0.0 and 1.5.0  -\tMultiple Brain Mets SRS 1.5.0  -       RT QA 1.0.0 and 1.5.0    Product Usage:  The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions.",
      "product_quantity": "US - 164 units; Outside the US - 333",
      "reason_for_recall": "There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting.",
      "recall_initiation_date": "20190311",
      "center_classification_date": "20190420",
      "termination_date": "20210512",
      "report_date": "20190501",
      "code_info": "Software revisions of affected RT Elements applications:  - Cranial SRS 1.0.0 and 1.5.0  - Spine SRS 1.0.0 and 1.5.0  - Multiple Brain Mets SRS 1.5.0  -       RT QA 1.0.0 and 1.5.0    Unique Identifier (UDI): GTIN for affected product(s): Cranial SRS 1.0 -7 04056481000554  Cranial SRS 1.5 -704056481140403  Spine SRS 1.0 -   04056481000547  Spine SRS 1.5 -  04056481140380  Multiple Brain Mets SRS 1.5 7 04056481006853                                           RT QA 1.0 -7     04056481007119  RT QA 1.5 -7     04056481140397    Model/catalogue numbers:  21702A     ELEMENTS MULTIPLE BRAIN METS SRS SUB.  21702-04C ELEMENTS MULTIPLE BRAIN METS SRS INST  21702-0 6 ELEMENTS MULTIPLE BRAIN METS SRS LICENSE  21702-12A ELEMENTS MULTIPLE BRAIN METS SRS SUB.  21702-36A ELEMENTS MULTIPLE BRAIN METS SRS SUB.  21702-60A ELEMENTS MULTIPLE BRAIN METS SRS SUB.  21712A     ELEMENTS MULTIPLE BRAIN METS SRS  21722A     ELEMENTS MULTIPLE BRAIN METS SRS SUB FOC  21722-12A ELEMENTS MULTIPLE BRAIN METS SRS SUB FOC  21741A        UPD TO ELEMENTS BRAIN MET PLAN  21742        ELEMENTS CRANIAL SRS  21742A     ELEMENTS CRANIAL SRS  21743         ELEMENTS CRANIAL SRS SUBSCRIPTION  21743A         ELEMENTS CRANIAL SRS SUBSCRIPTION  21743-01  ELEMENTS CRANIAL SRS LICENSE  ELEMENTS CRANIAL SRS LICENSE 1.5  ELEMENTS CRANIAL SRS INSTALLER  21743-02A ELEMENTS CRANIAL SRS INSTALLER 1.5  21743-12         ELEMENTS CRANIAL SRS SUBSCRIPTION  21743-36         ELEMENTS CRANIAL SRS SUBSCRIPTION  21743-60         ELEMENTS CRANIAL SRS SUBSCRIPTION  21744         ELEMENTS CRANIAL SRS SUBSCRIPTION FOC  21744A     ELEMENTS CRANIAL SRS SUBSCRIPTION FOC  21744-12    ELEMENTS CRANIAL SRS SUBSCRIPTION FOC  21744-36  ELEMENTS CRANIAL SRS SUBSCRIPTION FOC  21744-60  ELEMENTS CRANIAL SRS SUBSCRIPTION FOC  21745         ELEMENTS CRANIAL SRS (UPD)  21745A         ELEMENTS CRANIAL SRS (UPD)  21747         ELEMENTS SPINE SRS  21747A         ELEMENTS SPINE SRS  21748         ELEMENTS SPINE SRS SUBSCRIPTION  21748A         ELEMENTS SPINE SRS SUBSCRIPTION  21748-01    ELEMENTS SPINE SRS LICENSE  ELEMENTS SPINE SRS LICENSE 1.5  ELEMENTS SPINE SRS INSTALLER  21748-02A ELEMENTS SPINE SRS INSTALLER 1.5  21748-12         ELEMENTS SPINE SRS SUBSCRIPTION  21748-36    ELEMENTS SPINE SRS SUBSCRIPTION  21748-60         ELEMENTS SPINE SRS SUBSCRIPTION  21749         ELEMENTS SPINE SRS SUBSCRIPTION FOC  21749A         ELEMENTS SPINE SRS SUBSCRIPTION FOC  21749-12         ELEMENTS SPINE SRS SUBSCRIPTION FOC  21749-36         ELEMENTS SPINE SRS SUBSCRIPTION FOC  21749-60         ELEMENTS SPINE SRS SUBSCRIPTION FOC  21750         ELEMENTS SPINE SRS (UPD)  21750A     ELEMENTS SPINE SRS (UPD)  21762         RT QA 1.0  21762A         RT QA 1.5  21762-01   RT QA LICENSE  RT QA LICENSE 1.5  RT QA INSTALLER  21762-02A RT QA INSTALLER 1.5"
    }
  ]
}