{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "220288",
      "product_res_number": "Z-2405-2026",
      "event_date_initiated": "2026-05-12",
      "event_date_posted": "2026-06-11",
      "recall_status": "Open, Classified",
      "res_event_number": "98963",
      "product_code": "PNJ",
      "pma_numbers": [
        "P150035"
      ],
      "product_description": "Merlin\" Patient Care System (PCS) software\nMerlin\" PCS 3650 programmer Model 3330 software",
      "code_info": "Programmer Model 3650; Software Model 3330;  GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)",
      "firm_fei_number": "2017865",
      "recalling_firm": "Abbott Medical",
      "address_1": "15900 Valley View Ct",
      "city": "Sylmar",
      "state": "CA",
      "postal_code": "91342-3577",
      "additional_info_contact": "Alicia Swanson\n1-408-8453427",
      "reason_for_recall": "Software malfunction may occur during pacing capture threshold test of pacemaker resulting in  programmer not successfully communicating the command to terminate the test.",
      "root_cause_description": "Software Design Change",
      "action": "On May 12 Abbott issued a Urgent Medical Device Recall notification via sales representative. Abbott ask consignees to take the following actions:\n\nAbbott has developed updated Merlin PCS 3650 programmer software (v28.9.1 rev 1 or higher) that resolves this behavior. Beginning with this notification, your Abbott Representative will upgrade programmer software to this software version .   \n\nAbbott's service representative will proved a attestation  to acknowledge receipt of the notification and software update. \n\nPlease share this notification with others in your organization, as appropriate.",
      "product_quantity": "11182 programs",
      "distribution_pattern": "US Nationwide distribution including in the states of  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, \tGA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, \tNY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: Not provided yet",
      "openfda": {
        "device_name": "Leadless Pacemaker",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.3610",
        "device_class": "3",
        "pma_number": [
          "P150033",
          "P150035"
        ],
        "registration_number": [
          "3013288201",
          "2133641",
          "3002807314",
          "9612164",
          "3009380063",
          "9614453",
          "3003120897",
          "3006705815",
          "2182208",
          "3010849408",
          "2017865"
        ],
        "fei_number": [
          "3002806434",
          "3013288201",
          "3002807314",
          "3009380063",
          "3002807576",
          "3003120897",
          "3006705815",
          "3000203466",
          "2182208",
          "3010849408",
          "2017865"
        ]
      }
    }
  ]
}