{
  "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": "Malvern",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87995",
      "recalling_firm": "Siemens Medical Solutions USA, Inc",
      "address_1": "40 Liberty Blvd",
      "address_2": "",
      "postal_code": "19355",
      "voluntary_mandated": "FDA Mandated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution",
      "recall_number": "Z-1685-2021",
      "product_description": "Multitom RAX with software version VF10",
      "product_quantity": "26",
      "reason_for_recall": "Siemens identified two issues, In some cases, it is possible to perform an image acquisition although more than 20% of the beam does not  hit the detector. This may only occur when an organ program for the wall mode without top alignment is selected and the system is moved to the centred position. If afterwards the operator activates the top alignment, increases the collimation, and lifts the tube, the system allows examination even with the tube  being misaligned to the detector position. Hence, it is possible to overshoot the detector by more than 20%. From a clinical point of view, it is highly unlikely for the operator to trigger the examination as the misalignment is visible due to the light field being out of range.   AND In very rare cases it may occur that the calculated dose value exceeds the limit of 2 Gy. This may potentially occur only when an organ program for free exposure is selected, and the system uses incorrect (too small) source-to-image distance (SID) for calculating applied dose. Hence, the calculated dose is much higher than the actual applied dose causing the buzzer, which normally notifies the operator about the exceeded limit of 2 Gy, to get activated erroneously.",
      "recall_initiation_date": "20210420",
      "center_classification_date": "20210602",
      "termination_date": "20231108",
      "report_date": "20210609",
      "code_info": "software version VF10 model# 10860700",
      "more_code_info": ""
    }
  ]
}