{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "197248",
      "product_res_number": "Z-0475-2023",
      "event_date_initiated": "2022-11-21",
      "event_date_posted": "2022-12-09",
      "recall_status": "Open, Classified",
      "res_event_number": "91200",
      "product_code": "HRM",
      "product_description": "Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system",
      "code_info": "Serial Numbers:  20522001, 20722001, 21221001, 40222001, 40722001, 70722001, 80522002, 110722001, 150422001, 180322001, 211021001, 260722001, 290422001, 300122001, 270522001.  \n\n***EXPANSION 09/08/2023, Serial Numbers: 271222001, 100423002, 31022001, 180623001, 71222001, 210523002, 270922002, 120623002, 100123001, 130623001, 290922002, 300922002, 210223001, 220223001, 251122001, 281122001, 20623002, 60922001, 200822001, 40523001, 40523002, 270922001, 61122002, 20423001, 300523002, 190822002, 300922001, 280922001.",
      "firm_fei_number": "3000210133",
      "recalling_firm": "Leica Microsystems, Inc.",
      "address_1": "10 Parkway North blvd ste 300 10 Parkway North blvd",
      "address_2": "ste 300",
      "city": "deerfield",
      "state": "IL",
      "postal_code": "60089-6622",
      "additional_info_contact": "Andrew Suchomski \n224-727-0505",
      "reason_for_recall": "There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.",
      "root_cause_description": "Process control",
      "action": "The firm issued an URGENT FIELD SAFETY NOTICE to its consignees by email on 11/21/2022.  The notice explained the issue and stated that a Leica Microsystems representative would be contacting each facility to arrange an update to the the affected devices and advised the following:  Consignees can continue to use the system pending the field update; Ensure that all users of the affected microscope are aware of the Safety notes as described in section 3 of the respective user manual; Like any other instrument in the operating theater, the system may fail and Leica Microsystem (Schweiz) AG recommends that a backup system be kept available during the operation; Check before the operation :  Connect the power cable. + Switch on the microscope.  \n\nUPDATE 09/12/2023: Recall was expanded, and customers were sent the notification on about 09/11/2023.  Each consignee is requested to acknowledge receipt of the Field Safety Notice letter outlining the potential manufacturing defect, perform an initial inspection, indicate the results of the initial inspection, and provide contact information for further Leica Microsystems Representative verification of conformity/defect.",
      "product_quantity": "43 units",
      "distribution_pattern": "US Nationwide",
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        "device_name": "Microscope, Operating & Accessories, Ac-Powered, Ophthalmic",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4700",
        "device_class": "1"
      }
    }
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}