{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "194408",
      "product_res_number": "Z-1382-2022",
      "event_date_initiated": "2022-06-02",
      "event_date_created": "2022-07-13",
      "recall_status": "Open, Classified",
      "res_event_number": "90433",
      "product_code": "NOU",
      "k_numbers": [
        "K193586"
      ],
      "product_description": "Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation\n\nModel Number: 230000 \n\n\tIf the recalled product is a software, include version number: firmware versions 5.0.5 or earlier",
      "code_info": "Unique Device Identifier (UDI): UDI 07321822300004.  Serial number ranges in scope are: D******, K******, M01**** to M040124, where asterisk (*) denotes a digit from 0 to 9.",
      "firm_fei_number": "3010817335",
      "recalling_firm": "Breas Medical, Inc.",
      "address_1": "16 Esquire Rd",
      "city": "North Billerica",
      "state": "MA",
      "postal_code": "01862-2527",
      "additional_info_contact": "hris Southerland \n617-286-5509",
      "reason_for_recall": "A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained",
      "root_cause_description": "Device Design",
      "action": "Breas Medical contacted consignees initially by phone beginning  6/2/22 followed by email Urgent Medical Device Recall Firmware Upgrade letter  Letter states reason for recall, health risk and action to take:\nCustomers are required to identify all affected Vivo 45 LS ventilators and apply the firmware upgrade to firmware version 5.0.7 (or later) within 12 months.\n\nBreas has implemented a firmware correction to resolve the problem and can confirm that Vivo 45LS with firmware versions 5.0.7 or higher, distributed after March 29th, 2022 are not affected by this issue.\nConfirmation of receipt We kindly ask you to acknowledge receipt of this Recall Notice together with your choice to remedy the issue using attached reply form  Vivo 45 LS Firmware Upgrade Customer Reply Form.\nHelpline +1 (855) 436-8724",
      "product_quantity": "1,113 units",
      "distribution_pattern": "Nationwide",
      "openfda": {
        "k_number": [
          "K021981",
          "K123144",
          "K022750",
          "K233452",
          "K193586",
          "K034032",
          "K160481"
        ],
        "registration_number": [
          "3009077524",
          "3020283264",
          "8020893",
          "1316463",
          "3018094310",
          "3004428458",
          "2518422",
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          "3004604967",
          "3029227324",
          "9617566",
          "3002797442",
          "3011120183",
          "3003135857"
        ],
        "fei_number": [
          "3009077524",
          "3020283264",
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          "3003080079",
          "3018094310",
          "3004428458",
          "3001237338",
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          "3011120183",
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        ],
        "device_name": "Continuous, Ventilator, Home Use",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5895",
        "device_class": "2"
      }
    }
  ]
}