{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "194852",
      "product_res_number": "Z-1560-2022",
      "event_date_initiated": "2022-07-20",
      "event_date_created": "2022-08-22",
      "recall_status": "Open, Classified",
      "res_event_number": "90579",
      "product_code": "CBK",
      "k_numbers": [
        "K192604",
        "K201874"
      ],
      "product_description": "Maquet Critical Care AB/Getinge  \nServo-u Ventilator System, Part Number 6694800\nServo-n Ventilator System, Part Number 6688600\nServo-u MR ventilator: Part Number 6888800\nServo-air: Part Number 6882000",
      "code_info": "UDI-DI: \nServo-air: 73257100031183\nServo-u, Servo-n, Servo-u MR: 7325710001117R\n\nSerial 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      "firm_fei_number": "3013876692",
      "recalling_firm": "Getinge Usa Sales Inc",
      "address_1": "1 Geoffrey Way",
      "city": "Wayne",
      "state": "NJ",
      "postal_code": "07470-2035",
      "reason_for_recall": "Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue, it may lead to hypoventilation and consequently desaturation, with patient outcomes including hypoxemia and hypoxic injury, which might result in circulatory failure.",
      "root_cause_description": "Software in the Use Environment",
      "action": "On July 20, 2022, the firm sent Urgent Medical Device Correction letters to customers. Customers were instructed to examine their inventory immediately to see if they had any of the affected serial numbers on hand. Per the company, customers may continue to use their Ventilator System in accordance to the Users manual with extra attention to the following precautions as listed in chapter 1.2 Safety Guidelines of the User s manual:\n\no\tThe patient must never be left unattended when connected to the ventilator system\no\tAlways make sure that a manual resuscitator is readily available\n\nThe firm has updated the software platform for Servo systems to version 4.4 which contains bug fixes to address the technical alarms.\n\nIf you have any questions, please contact your Maquet Critical Care AB/Getinge representative or call the Maquet Critical Care AB/Getinge Customer Support at (603) 880-1433  (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).",
      "product_quantity": "37000 (11089 US)",
      "distribution_pattern": "Worldwide distribution. US nationwide, Poland, Spain, France, Germany, Czech Republic, Italy, Belgium, Estonia, Greece, Finland, Portugal, Netherlands, Romania, Austria, Slovakia, Lithuania, Ireland, Latvia, Norway, Sweden, Malaysia, China, Singapore, Taiwan, Iceland, Slovenia, Hungary, Bulgaria, Denmark, Croatia, United Kingdom, Russia, Hong Kong, United Arab Emirates, Canada, Switzerland, Australia, New Zealand, Serbia, Kenya, South Africa, Palestine, India, Colombia, Macau, Argentina, Mexico, Japan, Brazil, Israel, South Korea, Turkey, Peru, Ukraine, Thailand, Polynesia(French), Morocco, Saudi Arabia, Iran, Martinique (French), Costa Rica, Kuwait, Algeria, Saint Helena, Syria, Chile, Qatar, Fiji, Lebanon, Sri Lanka, Jordan, Oman, Pakistan, Ecuador, Botswana, Mozambique, Netherlands, Antilles, Bolivia, Andorra, Aruba, Faroe Islands, Egypt, Libya, Indonesia, Bahrain, Uruguay, Guadeloupe (French), Puerto Rico, Bosnia-Herzegovina, Paraguay, Nepal, Nicaragua, Vietnam, Tunisia, El Salvador, Tanzania, Papua New Guinea, Philippines, Nigeria, Myanmar, Dominican Republic, Cuba, Russian Federation, Honduras, Zimbabwe, Moldova, Republic of Bangladesh, Maldives, Angola Mauritius, Sudan, Turkmenistan, Panama, Rwanda, Brunei Darussalam, and Georgia.",
      "openfda": {
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