{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192761",
      "product_res_number": "Z-1012-2022",
      "event_date_initiated": "2022-03-04",
      "event_date_created": "2022-04-27",
      "recall_status": "Open, Classified",
      "res_event_number": "89877",
      "product_code": "MHX",
      "k_numbers": [
        "K130711"
      ],
      "product_description": "Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12.  For patient monitoring with Infinity M300 wireless telemetry devices.",
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(01)04049098001878(11)190117(21)1OQ80D-00060(93)MS26800-33, (01)04049098001878(11)181126(21)1OQ7XL-00757(93)MS26800-33, (01)04049098001878(11)181017(21)1OQ7XL-00638(93)MS26800-33, (01)04049098001878(11)180720(21)1OQ7XL-00366(93)MS26800-30, (01)04049098001878(11)181211(21)1OQ80D-00016(93)MS26800-30, (01)04049098001878(11)160622(21)12738M00594(93)MS26800-24, (01)04049098001878(11)160229(21)12738M00337(93)MS26800-20, (01)04049098001878(11)151110(21)12738M00125(93)MS26800-18, (01)04049098001878(11)151130(21)12738M00201(93)MS26800-18, (01)04049098001878(11)160122(21)12738M00293(93)MS26800-20.  Additional US Serial Numbers (w/o UDI): 12946M00316, 12946M00314, 12946M00269, 11553M00212, 11516M00186, 12051M00467, 11516M00155, 11516M00359, 11553M00646, 11097M00482, 12381M00904, 12381M00952, 11097M00313, 11407M00119, 11097M00661, 12051M00327, 11731M00246, 11731M00230, 11731M00245, 11516M00314, 11802M00360, 11553M00190, 11407M00061, 12381M00513, 12381M00557, 11187M00009, 12051M00412, 12381M00528, 12051M00381, 12381M00551, 12381M00566, 12381M00478, 12381M00505, 12381M00500,  11553M00883, 12381M00473, 12381M00464, 12381M00531, 11097M00451.",
      "firm_fei_number": "3005783425",
      "recalling_firm": "Draegar Medical Systems, Inc.",
      "address_1": "6 Tech Dr",
      "city": "Andover",
      "state": "MA",
      "postal_code": "01810-2434",
      "additional_info_contact": "Mike Kelhart\n215-660-2349",
      "reason_for_recall": "Software issue resulting in temporary loss of central monitoring functionality.",
      "root_cause_description": "Software design",
      "action": "A notification signed 03/08/2022, issued via certified mail on 03/11/2022 and 03/24/2022, notified customers of the impacted software versions, that a software update will be deployed to correct the issue, and provided interim instructions regarding use of USB devices.  Customers are to notify all users and return the acknowledgement form.  For questions please contact Michael Kelhart between the hours of 8:00 AM   4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).",
      "product_quantity": "1950 (1574 OUS + 376 US)",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IA, ID, IL, IN, LA, MN, MS, NC, NE, NH, NY, OH, PA, SD, TN, TX, WA, WI, and 58 additional foreign countries.",
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