{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "175517",
      "product_res_number": "Z-0160-2020",
      "event_date_initiated": "2019-07-23",
      "event_date_created": "2019-10-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-05-06",
      "res_event_number": "83508",
      "product_code": "MUE",
      "k_numbers": [
        "K173408"
      ],
      "product_description": "Mammomat Revelation with software version VC10 and Biopsy Option\n\nIntended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures",
      "code_info": "software version VC10 and Biopsy Option",
      "firm_fei_number": "2240869",
      "recalling_firm": "Siemens Medical Solutions USA, Inc",
      "address_1": "40 Liberty Blvd",
      "city": "Malvern",
      "state": "PA",
      "postal_code": "19355-1418",
      "additional_info_contact": "SAME\n610-219-4834",
      "reason_for_recall": "An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases",
      "root_cause_description": "Software design",
      "action": "Siemens issued the customer notification on 7/23/19 via XP018/19/S. The Advisory Notice provides the problem, health risk and action to take: provided steps to the operator on how to easily release patient and proceed with exam. Siemens is developing a corrective action to resolve the issue, which will be released via Update Instruction XP021/19/S.",
      "product_quantity": "139 WW (33 US)",
      "distribution_pattern": "Nationwide",
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        ],
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        "device_name": "Full Field Digital, System, X-Ray, Mammographic",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1715",
        "device_class": "2"
      }
    }
  ]
}