{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "158666",
      "product_res_number": "Z-0192-2018",
      "event_date_initiated": "2017-09-15",
      "event_date_created": "2017-11-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-05-29",
      "res_event_number": "78100",
      "product_code": "BYI",
      "k_numbers": [
        "K163378"
      ],
      "product_description": "Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability).  The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore.\n\n\nThe Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physicians choice of treatment. It is indicated for patients having difficulty with secretion clearance or the presence of atelectasis caused by mucus plugging.",
      "code_info": "Serial numbers S082VM0092, S122VM0171, S128VM0205, S151VM0242, S082VM0093, S122VM0172, S132VM0210, S151VM0243, S082VM0095, S122VM0175, S132VM0212, S152VM0251, S095VM0119, S122VM0176, S132VM0213, S157VM0257, S095VM0124, S124VM0177, S135VM0216, S157VM0261, S095VM0125, S124VM0178, S136VM0219, S158VM0264, S114VM0152, S124VM0180, S136VM0222, S158VM0266, S119VM0158, S124VM0181, S136VM0223, S158VM0267, S119VM0160, S126VM0187, S138VM0224, S158VM0268, S119VM0161, S126VM0193, S138VM0226, S158VM0271, S119VM0162, S126VM0198, S146VM0227, S158VM0273, S122VM0165, S126VM0199, S146VM0229, S159VM0276, S122VM0166, S128VM0202, S146VM0230, S160VM0279, S122VM0168, S128VM0203, S151VM0238, S167VM0289, S122VM0170, S128VM0204, S151VM0240, and S167VM0291.",
      "firm_fei_number": "2183816",
      "recalling_firm": "HILL-ROM MANUFACTURING, INC.",
      "address_1": "1020 County Road F W",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55126-2910",
      "additional_info_contact": "Hill-Rom Technical Support\n800-426-4224",
      "reason_for_recall": "Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subject to an EMI if they come into direct contact with the Monarch device.",
      "root_cause_description": "Other",
      "action": "Phone calls were initiated September 15, 2017,  to the customers, who are users.\n\nThe expanded recall was initiated by letter dated  November 13, 2017,via FedEx with delivery confirmation to both the users identified in the September notification and to the users who later received the recalled product.   (Two local consignees will be provided the letter in person and one consignee will be sent the letter via USPS.)  For further questions, please call (800) 426-4224.",
      "product_quantity": "60 devices",
      "distribution_pattern": "USA (nationwide) Distribution to the states of:  AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, MN, MO, NE, OH,  OK, OR, TN, TX, VA, WA, WI, and WV.  Internationally to Canada.  There was no military/government distribution.",
      "openfda": {
        "k_number": [
          "K222496",
          "K252849",
          "K060439",
          "K974849",
          "K913014",
          "K031876",
          "K012928",
          "K882604",
          "K842608",
          "K053248",
          "K790675",
          "K802646",
          "K812151",
          "K201490",
          "K880597",
          "K024309",
          "K801982",
          "K132794",
          "K100749",
          "K892862",
          "K142482",
          "K931988",
          "K173603",
          "K821570",
          "K853965",
          "K946083",
          "K233441",
          "K884098",
          "K940986",
          "K800713",
          "K121587",
          "K771876",
          "K972859",
          "K813438",
          "K855129",
          "K965192",
          "K203209",
          "K242063",
          "K812803",
          "K982889",
          "K250860",
          "K040367",
          "K122480",
          "K812166",
          "K860510",
          "K051383",
          "K901026",
          "K993629",
          "K883899",
          "K063645",
          "K863658",
          "K240959",
          "K821265",
          "K103176",
          "K163378",
          "K936121",
          "K802399",
          "K121170"
        ],
        "device_name": "Percussor, Powered-Electric",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5665",
        "device_class": "2",
        "registration_number": [
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        "fei_number": [
          "3006666710",
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      }
    }
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}