{
  "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,
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  },
  "results": [
    {
      "cfres_id": "185799",
      "product_res_number": "Z-1137-2021",
      "event_date_initiated": "2021-01-06",
      "event_date_created": "2021-02-19",
      "recall_status": "Open, Classified",
      "res_event_number": "87314",
      "product_code": "MNT",
      "k_numbers": [
        "K082660"
      ],
      "product_description": "PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.",
      "code_info": "Battery Model/Part Number:  1076374 Lot Code: M94663-P1",
      "firm_fei_number": "2518422",
      "recalling_firm": "Respironics California, LLC",
      "address_1": "2271 Cosmos Ct",
      "city": "Carlsbad",
      "state": "CA",
      "postal_code": "92011-1517",
      "additional_info_contact": "760-918-7300",
      "reason_for_recall": "Due to unqualified \"design verification\" batteries being shipped to customers.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 01/06/2021, the firm contacted via telephone calls and then on 01/29/2021 sent  a follow-up \"URGENT - Medical Device Removal\" letter via priority mail to customers to inform them that the Recalling Firm shipped unqualified batteries to customers. These batteries are similar to production batteries but did complete final qualification testing.  Potential hazards that may result, In a worst-case scenario, a battery failure could occur while in use on a patient during intra-hospital transport or when not connected to AC power. In both situations, the patient could lose ventilatory assistance and experience severe hypoxemia.\n\nCustomers are provided instructions on how to identify affected products:\nCheck the label of backup batteries (PN 1076374) received on or after\nNovember 25, 2020, or installed on affected units. If the battery has LOT M94663-P1, it is affected.\n\nCustomers are instructed to:\n1. If the batteries have been installed in ventilators, remove the\nventilators from service until a field service representative or\napproved service provider schedules a visit and replaces the battery.\n2. If waiting for a field service representative or approved service\nprovider is not possible given their current census, contact Recalling Firm by email at HRC.Recall.Response@Philips.com to request a replacement\nbattery that trained biomed can install.\n3. If the affected battery has not been installed in a ventilator, quarantine\nthe battery until a Recalling Firm representative can replace it.\n4. Complete, sign, and return the Acknowledgment and Receipt Form at\nthe end of this letter.\n\nFor further information and questions - contact the local representatives or Customer Care Solutions Center (24/7) +1-800-722-9377",
      "product_quantity": "94 batteries",
      "distribution_pattern": "U.S. Nationwide distribution including in the states of FL, GA, IA, IA, IL. IL, MN, MO, NC, ND, OH, TX, TX and UT.",
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          "K233643",
          "K090113",
          "K242931",
          "K240779",
          "K974539",
          "K082660",
          "K170367",
          "K113640",
          "K955324",
          "K121623",
          "K122715",
          "K003075",
          "K990574",
          "K951264",
          "K060044",
          "K982454",
          "K973004"
        ],
        "device_name": "Sv70 Ventilator",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5895",
        "device_class": "2",
        "registration_number": [
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