{
  "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": "187470",
      "product_res_number": "Z-1861-2021",
      "event_date_initiated": "2021-05-11",
      "event_date_posted": "2021-06-15",
      "recall_status": "Open, Classified",
      "res_event_number": "87939",
      "product_code": "FQO",
      "product_description": "Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor.\n\nModel: FS32",
      "code_info": "Serial Numbers: \n1504-314-00-1-0002 up to 2006-314-00-1-0185\n\n***UPDATED 12/10/21***\nRecall expanded to include Rev 3. Complete list of recalled Serial Numbers:\n\n1504-314-00-1-0002\n1504-314-00-1-0003\n1504-314-00-1-0004\n1508-314-00-1-0005\n1508-314-00-1-0006\n1508-314-00-1-0007\n1508-314-00-1-0008\n1509-314-00-1-0009\n1509-314-00-1-0010\n1509-314-00-1-0011\n1509-314-00-1-0012\n1510-314-00-1-0013\n1510-314-00-1-0014\n1601-314-00-1-0016\n1601-314-00-1-0017\n1610-314-00-1-0018\n1610-314-00-1-0019\n1610-314-00-1-0020\n1610-314-00-1-0021\n1610-314-00-1-0022\n1610-314-00-1-0023\n1610-314-00-1-0024\n1610-314-00-1-0025\n1610-314-00-1-0026\n1610-314-00-1-0027\n1610-314-00-1-0028\n1610-314-00-1-0029\n1610-314-00-1-0030\n1610-314-00-1-0031\n1610-314-00-1-0032\n1802-314-00-1-0033\n1802-314-00-1-0034\n1802-314-00-1-0035\n1802-314-00-1-0036\n1802-314-00-1-0037\n1802-314-00-1-0038\n1802-314-00-1-0039\n1802-314-00-1-0040\n1802-314-00-1-0041\n1802-314-00-1-0042\n1803-314-00-1-0043\n1803-314-00-1-0044\n1803-314-00-1-0045\n1803-314-00-1-0046\n1803-314-00-1-0047\n1803-314-00-1-0048\n1803-314-00-1-0049\n1803-314-00-1-0050\n1803-314-00-1-0051\n1803-314-00-1-0052\n1809-314-00-1-0053\n1809-314-00-1-0054\n1809-314-00-1-0055\n1809-314-00-1-0056\n1809-314-00-1-0057\n1809-314-00-1-0058\n1809-314-00-1-0059\n1809-314-00-1-0060\n1809-314-00-1-0061\n1809-314-00-1-0062\n1809-314-00-1-0063\n1809-314-00-1-0064\n1810-314-00-1-0065\n1810-314-00-1-0066\n1810-314-00-1-0067\n1810-314-00-1-0068\n1810-314-00-1-0069\n1810-314-00-1-0070\n1811-314-00-1-0071\n1811-314-00-1-0072\n1811-314-00-1-0073\n1811-314-00-1-0074\n1811-314-00-1-0075\n1811-314-00-1-0076\n1811-314-00-1-0077\n1811-314-00-1-0078\n1811-314-00-1-0079\n1811-314-00-1-0080\n1811-314-00-1-0083\n1811-314-00-1-0084\n1811-314-00-1-0085\n1811-314-00-1-0087\n1811-314-00-1-0088\n1811-314-00-1-0089\n1811-314-00-1-0090\n1901-314-00-1-0091\n1901-314-00-1-0092\n1901-314-00-1-0093\n1901-314-00-1-0094\n1901-314-00-1-0095\n1901-314-00-1-0096\n1901-314-00-1-0097\n1901-314-00-1-0098\n1901-314-00-1-0099\n1901-314-00-1-0100\n1901-314-00-1-0101\n1901-314-00-1-0102\n1901-314-00-1-0103\n1901-314-00-1-0104\n1901-314-00-1-0105\n1901-314-00-1-0106\n1901-314-00-1-0107\n1901-314-00-1-0108\n1901-314-00-1-0109\n1904-314-00-1-0121\n1904-314-00-1-0127\n2005-314-00-1-0131\n2005-314-00-1-0132\n2005-314-00-1-0133\n2005-314-00-1-0134\n2005-314-00-1-0135\n2005-314-00-1-0136\n2005-314-00-1-0137\n2005-314-00-1-0138\n2005-314-00-1-0139\n2005-314-00-1-0140\n2005-314-00-1-0141\n2005-314-00-1-0142\n2006-314-00-1-0143\n2006-314-00-1-0144\n2006-314-00-1-0145\n2006-314-00-1-0146\n2011-314-00-2-0002\n2011-314-00-2-0003\n2011-314-00-2-0004\n2011-314-00-2-0005\n2011-314-00-2-0006\n2011-314-00-2-0007\n2011-314-00-2-0008\n2011-314-00-2-0009\n2011-314-00-2-0010\n2011-314-00-2-0011\n2011-314-00-2-0012\n2011-314-00-2-0013\n2011-314-00-2-0014\n2011-314-00-2-0015\n2011-314-00-2-0016\n2011-314-00-2-0017\n2011-314-00-2-0018\n2011-314-00-2-0019\n2011-314-00-2-0020\n2011-314-00-2-0021\n2011-314-00-2-0022\n2011-314-00-2-0023\n2011-314-00-2-0024\n2011-314-00-2-0025\n2011-314-00-2-0026\n2011-314-00-2-0027\n2011-314-00-2-0028\n2011-314-00-2-0029\n2011-314-00-2-0030\n2011-314-00-2-0031\n2011-314-00-2-0032\n2011-314-00-2-0033\n2011-314-00-2-0034\n2011-314-00-2-0035\n2011-314-00-2-0036\n2011-314-00-2-0037\n2011-314-00-2-0038\n2011-314-00-2-0039\n2011-314-00-2-0040\n2011-314-00-2-0041\n2011-314-00-2-0042\n2011-314-00-2-0043\n2011-314-00-2-0044\n2011-314-00-2-0045\n2011-314-00-2-0046\n2011-314-00-2-0047\n2011-314-00-2-0048\n2011-314-00-2-0049\n2011-314-00-2-0050\n2011-314-00-2-0051\n2011-314-00-2-0052\n2011-314-00-2-0053\n2011-314-00-2-0054\n2011-314-00-2-0055\n2011-314-00-2-0056\n2011-314-00-2-0057\n2011-314-00-2-0058\n2011-314-00-2-0059\n2011-314-00-2-0060\n2011-314-00-2-0061\n2011-314-00-2-0062\n2011-314-00-2-0063\n2011-314-00-2-0064\n2011-314-00-2-0065\n2011-314-00-2-0066\n2011-314-00-2-0067\n2011-314-00-2-0068\n2011-314-00-2-0069\n2011-314-00-2-0070\n2011-314-00-2-0071\n2011-314-00-2-0072\n2011-314-00-2-0073\n2011-314-00-2-0074\n2011-314-00-2-0075\n2011-314-00-2-0076\n2011-314-00-2-0077\n2011-314-00-2-0078\n2011-314-00-2-0079\n2011-314-00-2-0080\n2011-314-00-2-0081\n2011-314-00-2-0082\n2011-314-00-2-0083\n2011-314-00-2-0084\n2011-314-00-2-0085\n2011-314-00-2-0086\n2011-314-00-2-0087\n2011-314-00-2-0088\n2011-314-00-2-0089\n2011-314-00-2-0090\n2011-314-00-2-0091\n2011-314-00-2-0092\n2011-314-00-2-0093\n2011-314-00-2-0094\n2011-314-00-2-0095\n2011-314-00-2-0096\n2011-314-00-2-0097\n2011-314-00-2-0098\n2011-314-00-2-0099\n2011-314-00-2-0100\n2011-314-00-2-0101\n2011-314-00-2-0102\n2011-314-00-2-0103\n2011-314-00-2-0104\n2011-314-00-2-0105\n2011-314-00-2-0106\n2011-314-00-2-0107\n2011-314-00-2-0108\n2011-314-00-2-0109\n2011-314-00-2-0110\n2011-314-00-2-0111\n2011-314-00-2-0112\n2011-314-00-2-0113\n2011-314-00-2-0114\n2011-314-00-2-0115\n2011-314-00-2-0116\n2011-314-00-2-0117\n2011-314-00-2-0118\n2011-314-00-2-0119\n2011-314-00-2-0120\n2011-314-00-2-0121\n2011-314-00-2-0122\n2011-314-00-2-0123\n2011-314-00-2-0124\n2011-314-00-2-0125\n2011-314-00-2-0126\n2011-314-00-2-0127\n2011-314-00-2-0128\n2011-314-00-2-0129\n2011-314-00-2-0130\n2011-314-00-2-0131\n2011-314-00-2-0132\n2011-314-00-2-0133\n2011-314-00-2-0134\n2011-314-00-2-0135\n2011-314-00-2-0136\n2011-314-00-2-0137\n2011-314-00-2-0138\n2011-314-00-2-0139\n2011-314-00-2-0140\n2011-314-00-2-0141\n2011-314-00-2-0142\n2011-314-00-2-0143\n2011-314-00-2-0144\n2011-314-00-2-0145\n2011-314-00-2-0146\n2011-314-00-2-0147\n2011-314-00-2-0148\n2011-314-00-2-0149\n2011-314-00-2-0150\n2011-314-00-2-0151\n2011-314-00-2-0152\n2011-314-00-2-0153\n2011-314-00-2-0154\n2011-314-00-2-0155\n2011-314-00-2-0156\n2011-314-00-2-0157\n2011-314-00-2-0158\n2011-314-00-2-0160\n2011-314-00-2-0161\n2011-314-00-2-0162\n2011-314-00-2-0163\n2011-314-00-2-0165\n2103-314-00-2-0170",
      "firm_fei_number": "1825014",
      "recalling_firm": "Skytron, Div. The KMW Group, Inc",
      "address_1": "5085 Corporate Exchange Blvd SE",
      "city": "Grand Rapids",
      "state": "MI",
      "postal_code": "49512-5515",
      "additional_info_contact": "SAME\n616-656-2900",
      "reason_for_recall": "Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from its attachment point, causing injury to patients or staff",
      "root_cause_description": "Device Design",
      "action": "Skytron issued Urgent Medical Device Correction notice on 5/11/21. Letter states reason for recall, health risk and action to take:\n\nIdentify your FS32 monitor bracket(s). Serial numbers can be found on the UDI label located on the back of the bracket.\n\nInspect your FS32 monitor bracket(s) per the instructions on the final page of this document. Remove from service any bracket where evidence is identified that the device may fail.\n\nSkytron authorized representatives have been directed to contact you and schedule a service visit. Please contact Erin Woolf, at 616-656-2998 or ewoolf@skytron.us with any questions.\n\n***UPDATED 12/10/21***\n\nOn November 22, 2021, the firm sent updated letters due to an expansion of the recall scope. Revision 3 models of the FS32 Monitor Bracket were added to the recall.\n\nCustomer instructions remain the same.",
      "product_quantity": "278 units  US; 7 units OUS",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Japan.",
      "openfda": {
        "k_number": [
          "K955750",
          "K961742",
          "K932186",
          "K864295",
          "K915141",
          "K921143",
          "K951854",
          "K880227",
          "K920890",
          "K971307",
          "K240598",
          "K831086",
          "K922371",
          "K841115",
          "K961886",
          "K921297",
          "K921626",
          "K882660",
          "K942043",
          "K221410",
          "K942486",
          "K940068",
          "K090136",
          "K926525",
          "K864325",
          "K926463",
          "K941150",
          "K963506",
          "K953980",
          "K950192",
          "K936308",
          "K972810",
          "K930493",
          "K971988",
          "K924700"
        ],
        "registration_number": [
          "",
          "1643116",
          "3031025858",
          "3021839632",
          "3006105501",
          "3015179588",
          "3001104093",
          "3027847726",
          "1047843",
          "3002807616",
          "3019878714",
          "3035641086",
          "3007836437",
          "3013522950",
          "2030380",
          "3010373494",
          "2027467",
          "3032910452",
          "9610612",
          "2183744",
          "3004137296",
          "3026311463",
          "3040337865",
          "8010652",
          "3006467297",
          "3031563141",
          "3007055152",
          "3043654660",
          "3012708860",
          "3015223105",
          "3029970239",
          "2031963",
          "3017181414",
          "2518443",
          "3010326005",
          "3003950207",
          "2921578",
          "3008786200",
          "3010037894",
          "3010373530",
          "1000122786",
          "1825014",
          "3007591382",
          "3010373263",
          "3035111606",
          "3005285078",
          "3014739961",
          "3005698350",
          "8021896",
          "3023808059",
          "3011910987",
          "9611500",
          "3007682310",
          "3037012186",
          "1033902",
          "1043572",
          "3013685983",
          "3044829820",
          "3011580044",
          "3003768277",
          "3006800085",
          "3009028104",
          "3042471748",
          "3012272052",
          "3007014520",
          "3026790309",
          "1054713",
          "3015978022",
          "3003786160",
          "3010673832",
          "9680168",
          "3003477135",
          "3017847344",
          "2936485",
          "2221819",
          "1066427",
          "3006142326"
        ],
        "fei_number": [
          "3007513035",
          "",
          "1643116",
          "3031025858",
          "3006105501",
          "3015179588",
          "3001104093",
          "3027847726",
          "1047843",
          "3002807616",
          "3019878714",
          "3002975342",
          "3035641086",
          "3007836437",
          "3013522950",
          "1000519805",
          "3010373494",
          "2027467",
          "3032910452",
          "2183744",
          "3004137296",
          "3026311463",
          "3040337865",
          "3002806315",
          "3006467297",
          "3031563141",
          "3007055152",
          "3043654660",
          "3012708860",
          "3015223105",
          "3029970239",
          "3017181414",
          "2518443",
          "3010326005",
          "3003950207",
          "2921578",
          "3008786200",
          "3010037894",
          "3010373530",
          "1000122786",
          "1825014",
          "3007591382",
          "3010373263",
          "3035111606",
          "3005285078",
          "3014739961",
          "1000114111",
          "3005698350",
          "1000125341",
          "3002807880",
          "3023530182",
          "3023808059",
          "3011910987",
          "1841",
          "1000295034",
          "1000214453",
          "3037012186",
          "1033902",
          "1043572",
          "3013685983",
          "3044829820",
          "3001168737",
          "3011580044",
          "3006800085",
          "3009028104",
          "3042471748",
          "3012272052",
          "3007014520",
          "3026790309",
          "3015978022",
          "3003786160",
          "3010673832",
          "3003477135",
          "3017847344",
          "2936485",
          "2221819",
          "3006142326"
        ],
        "device_name": "Table, Operating-Room, Ac-Powered",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4960",
        "device_class": "1"
      }
    }
  ]
}