{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Indianola",
      "address_1": "1 Medrad Dr",
      "reason_for_recall": "The root cause investigation showed that the under-volume hazard can occur  when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may create a non-optimal priming condition that could lead to under-infusion.",
      "address_2": "",
      "product_quantity": "133",
      "code_info": "Material numbers: 3032458, 3007301, 3010432 with serial numbers: 10054  37918  37921  36714  36721  108  40596  23834  10065  39533  20092  29884  33423  10026  10028  10032  10035  10069  29881  30351  23741  27877  10095  20693  30548  33316  21089  10123  10008  24272  37177  25989  39003  39009  38894  38894  38840  38843  34894  38833  35824  38846  26107  37073  37472  10058  10010  10076  24707  10091  38400  38403  38404  38405  40390  10093  38999  39434  37351  37359  37358  37367  40225  34619  10127  38989  37298  37461  37462  35172  35173  35175  35176  34630  25348  36811  33443  36432  38007  31538  33315  35434  20178  25804  10280  28893  31196  35454  38011  29248  30219  39034  38940  36975  23511  36937  36966  36086  10030  10027  37839  35554  33020  10212  10145  38631  31620  37996  38906  39201  38659  31537  33314  38895  39049  38930  38319  38995  38996  38678  30429  30540  10064  38322  38196  38197  39509  33230  38831  10107  37431  26933  39171  39191  34829  37684  41169",
      "center_classification_date": "20150528",
      "distribution_pattern": "Nationwide Distribution",
      "state": "PA",
      "product_description": "MEDRAD¿ Stellant CT Injector  System with Certegra  Workstation;  intended  for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies  in computed tomography (CT) applications.",
      "report_date": "20150603",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Medrad Inc dba Bayer R&I",
      "recall_number": "Z-1686-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "71296",
      "termination_date": "20150616",
      "more_code_info": "",
      "recall_initiation_date": "20130920",
      "postal_code": "15051-9759",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}