{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Malvern",
      "address_1": "51 Valley Stream Pkwy",
      "reason_for_recall": "The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur.",
      "address_2": "",
      "product_quantity": "132",
      "code_info": "model numbers: 10432914, 10432915, 10684331, 10684332, 10684333, 10684334 with serial numbers:   45398  45788  59092  60099  41953  45805  52255  45812  52250  52171  52264  41980  41448  60092  41727  60038  60062  59071  59065  60061  60082  62032  41548  52168  59032  62014  60086  57118  52108  41628  60070  45249  62027  41699  41701  59090  60060  60052  41903  52082  41473  45537  41749  41457  42060  41383  41769  45778  62018  45628  52200  42033  52135  52195  41317  41529  45371  57060  41862  59101  52150  52240  52128  41608  41624  42012  45160  45387  45603  45526  41476  45155  52251  41746  62020  41503  59120  62024  59096  62025  41897  59109  45681  41362  60053  60055  59087  60085  41819  59116  62031  52172  52057  52153  45623  59112  41844  41874  59104  45850  41621  52192  60054  41595  45667  41353  60063  57254  41556  60079  45408  41654  52021  52072  57146  45239  59035  59076  41629  41802  41952  45230  45251  41979  45237  45205  45694  41671  45507  41389  41295  60091",
      "center_classification_date": "20150320",
      "distribution_pattern": "Nationwide Distribution.",
      "state": "PA",
      "product_description": "MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ;  indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.",
      "report_date": "20150401",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Medical Solutions USA, Inc",
      "recall_number": "Z-1308-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "70712",
      "termination_date": "20160817",
      "more_code_info": "",
      "recall_initiation_date": "20150309",
      "postal_code": "19355-1406",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}