{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "country": "United States",
      "city": "Malvern",
      "address_1": "40 Liberty Blvd",
      "reason_for_recall": "Software changes now available to address several issues",
      "address_2": "",
      "product_quantity": "104 systems",
      "code_info": "Device Model Numbers: 10863171, 10863172, 10863173    Serial Numbers:  401018  221363  221402  310364  222027  221225  130653  310395  310397  221110  130765  310310  450002  130848  130849  130692  310536  131037  221199  131200  130773  401005  130874  130706  401004  310363  400047  131011  130784  401062  310361  221192  221373  401070  222060  310544  310365  310388  310348  221280  401024  130772  310486  130628  130777  130998  131160  222025  221403  221388  221344  131127  222023  130716  221345  310472  130808  221198  130734  310396  102021  310460  131192  131132  310410  221235  130563  130916  130611  401026  221411  130770  310379  130984  221233  222008  400065  221204  131165  130837  130754  131057  130816  221390  221319  221296  131006  221109  130631  401007  221254  131131  130889  130803  400042  130711  130751  221425  130761  131012  100771  310418  130697  131013",
      "center_classification_date": "20170327",
      "distribution_pattern": "Nationwide Distribution.",
      "state": "PA",
      "product_description": "Syngo.x, Picture archiving and communication system  Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. Syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.via integrates Radiology Information Systems (RIS) to enable customer specific workflows. Syngo.via allows to use a variety of advanced applications (clinical applications) designed for syngo.via just as the predicate device syngo.x,(K092519,cleared on August 27, 2009). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device. Syngo.via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. Syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. Syngo.via Data Management ...ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images with regard to data security, open interfaces, storage media and central system administration, to provide a flexible storage hierarchy",
      "report_date": "20170405",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Medical Solutions USA, Inc",
      "recall_number": "Z-1688-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76700",
      "termination_date": "20170612",
      "more_code_info": "",
      "recall_initiation_date": "20170306",
      "postal_code": "19355-1418",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}