{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "122435",
      "product_res_number": "Z-0142-2014",
      "event_date_initiated": "2013-09-24",
      "event_date_posted": "2013-11-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-07-10",
      "res_event_number": "66464",
      "product_code": "DTQ",
      "k_numbers": [
        "K071318"
      ],
      "product_description": "S5 Heart-lung machine, Stockert S5 System.  Catalogue No: 48-30/40/50-00.\r\n\r\nThe Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.",
      "code_info": "Serial Numbers: 48E00235,48E00339,48E00342,48E01753,48E02767,48E02753,48E02745,48E02746,48E02748,48E02416,48E01033,480E1038,48E01040,48E01041,48E01043,48E01044,48E01051,48E02631,48E01183,48E02758,48E02764,48E01832,48E01834,48E02278,48E02722,48E02732,48E02326,48E02797,48E02793,48E02791,48E02781,48E02785,48E02786,48E02783,48E02772,48E02802,48E02778,48E02784,48E02788,48E02789,48E02779,48E02792,48E02790,48E02771,48E02773,48E02776,48E02799,48E02801",
      "firm_fei_number": "3002808267",
      "recalling_firm": "Sorin Group Deutschland GmbH",
      "address_1": "Lindberghstrasse 25 25 lindberghstrasse",
      "city": "Munchen",
      "country": "Germany",
      "additional_info_contact": "Cheri Voorhees\n303-467-6527",
      "reason_for_recall": "Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.",
      "root_cause_description": "Software Manufacturing/Software Deployment",
      "action": "Sorin Group sent an Urgent Field Safety Notice dated September 24, 2013, to all affected customers.   The letter informed users of the potential for failing of automatic cardioplegia delivery function and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to update the firmware on site.  Customers were asked to complete the Response form to confirm they had received, read and understood the Field Notice.  For questions regarding this recall call 303-467-6527.",
      "product_quantity": "84",
      "distribution_pattern": "Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.",
      "openfda": {
        "k_number": [
          "K842138",
          "K011088",
          "K052555",
          "K813034",
          "K863960",
          "K090006",
          "K822068",
          "K133598",
          "K021694",
          "K210130",
          "K861388",
          "K002116",
          "K071318",
          "K173834",
          "K943803",
          "K871131",
          "K221373",
          "K862973",
          "K851615",
          "K080832",
          "K870976",
          "K801097",
          "K915183",
          "K151349",
          "K060053",
          "K092463",
          "K190282",
          "K030141",
          "K070213",
          "K091007",
          "K020571",
          "K163531",
          "K772001",
          "K062396",
          "K103762",
          "K002118",
          "K863541",
          "K982014",
          "K102726",
          "K022947",
          "K942582",
          "K770002",
          "K232291",
          "K153376",
          "K221895",
          "K964017",
          "K202125",
          "K950990",
          "K172220",
          "K131041",
          "K851614",
          "K093882"
        ],
        "registration_number": [
          "2916596",
          "9680841",
          "3007427881",
          "1828100",
          "3010163695",
          "3042990265",
          "2184009",
          "1218444",
          "8010762",
          "9611109",
          "3019807891",
          "3006073153",
          "3002807090",
          "3010703925",
          "3009507273",
          "3005941719",
          "3011554160",
          "3001589655"
        ],
        "fei_number": [
          "2916596",
          "1000116158",
          "3007427881",
          "1828100",
          "3010163695",
          "3042990265",
          "1218444",
          "3002808267",
          "3019807891",
          "3006073153",
          "3010703925",
          "3009649876",
          "3006003617",
          "3002807111",
          "3009507273",
          "3011554160",
          "3001589655",
          "3005426550"
        ],
        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}