{
  "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": "Ongoing",
      "city": "Unterschleisheim",
      "state": "",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85392",
      "recalling_firm": "Tomtec Imaging Systems Gmbh",
      "address_1": "Edisonstr. 6",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US:AL, AZ, CA, CT, IL, MA, MI,NC, NJ, NY, OH, PA, RI, TX, VA.  OUS: Australia, Canada, Czech Republic, France, Germany, Italy, Latvia, Sweden, Switzerland, United Kingdom.",
      "recall_number": "Z-2496-2020",
      "product_description": "TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system.    Software Versions and applicable UDI:    TTA 1.2  release prior to UDI requirement  TTA2.00.01  release prior to UDI requirement  TTA2.11.01  release prior to UDI requirement  TTA2.11.02  release prior to UDI requirement  TTA2.20.01  UDI: (01)04260361440143(11)160429(10)20.01  TTA2.20.10  UDI:(01)04260361440143(11)160809(10)20.10  TTA2.20.13  UDI:(01)04260361440143(11)160922(10)20.13  TTA2.20.14  UDI:(01)04260361440143(11)161028(10)20.14  TTA2.20.15  UDI: (01)04260361440143[11]161207[10]20.15  TTA2.20.16  UDI:(01)04260361440143(11)170127(10)20.16  TTA2.20.18  UDI:(01)04260361440143(11)170622(10)20.18",
      "product_quantity": "62 units",
      "reason_for_recall": "The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from one study might be stored to another study.",
      "recall_initiation_date": "20190923",
      "center_classification_date": "20200704",
      "report_date": "20200715",
      "code_info": "The affected product versions are TOMTEC-ARENA, TTA 2.20 and lower, with modules 4D LV-Analysis, 4D RV-Function, 4D MV-Assessment, 3D Cardio-View, 4D Sono-Scan, Echo-Com, 2D Cardiac Performance Analysis, and QAngio.",
      "more_code_info": ""
    }
  ]
}