{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "84856",
      "product_res_number": "Z-0134-2010",
      "event_date_initiated": "2009-08-31",
      "event_date_posted": "2009-11-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-04-14",
      "res_event_number": "53177",
      "product_code": "LMB",
      "product_description": "Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power).\n\nIntended use is to act as a medical data backup and disaster recovery plan.",
      "code_info": "All accounts that have OfficePACS Power and are enrolled in Guardian Services backup.",
      "firm_fei_number": "3002907767",
      "recalling_firm": "Stryker Imaging",
      "address_1": "1410 Lakeside Pkwy Ste 600 1410 Lakeside Pkwy",
      "address_2": "Ste 600",
      "city": "Flower Mound",
      "state": "TX",
      "postal_code": "75028-4027",
      "reason_for_recall": "Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis.",
      "root_cause_description": "Other",
      "action": "Stryker Imaging issued an \"Urgent: Device Correction\" notice dated August 18, 2009.  Customers were notified of the defective product and informed that Stryker will be in contact shortly to coordinate the product correction.  Actions to be taken during the interim were also detailed.\n\nFor further information, contact Stryker Imaging at 1-972-410-7100.",
      "product_quantity": "12 devices affected",
      "distribution_pattern": "Nationwide Distribution -- AR, TN, IL, GA, TX, WA, MI, PA, and MS.",
      "openfda": {
        "k_number": [
          "K980243",
          "K891690",
          "K903806",
          "K955237",
          "K961680",
          "K984405",
          "K915094",
          "K951141",
          "K950630",
          "K905488",
          "K884990",
          "K983447",
          "K844132",
          "K882184",
          "K923680",
          "K873048",
          "K964274",
          "K971451",
          "K942558",
          "K951942",
          "K960326",
          "K955232",
          "K952888",
          "K960981",
          "K972380",
          "K843349",
          "K952238",
          "K992131",
          "K963936",
          "K885327",
          "K833525",
          "K934889",
          "K955184",
          "K862842",
          "K884148",
          "K891485",
          "K926348",
          "K901956",
          "K973413",
          "K935498",
          "K964803",
          "K933115",
          "K960941",
          "K950279",
          "K921275",
          "K931410",
          "K914728",
          "K934888",
          "K973463",
          "K901118",
          "K963395",
          "K961160",
          "K971848",
          "K945654",
          "K863286"
        ],
        "registration_number": [
          "1647172",
          "3021023132",
          "3014232530",
          "3018050916",
          "3043648115",
          "3010583458",
          "3003604053",
          "3005205318",
          "9610612",
          "1643264",
          "1320925",
          "3030516433",
          "1320894",
          "3002807616",
          "1000263389",
          "3011215096",
          "1063008",
          "3008347129",
          "3004915908",
          "3005083075",
          "3009219448",
          "3005439497",
          "3009341091",
          "3004730352",
          "2936485",
          "3016527960",
          "1000181430",
          "3007142723",
          "8043980",
          "2954921",
          "3011344631",
          "3004158384",
          "3043496873",
          "2916714",
          "3038614464",
          "3009831823",
          "3017697447",
          "3004026651",
          "3014991167",
          "3033043422",
          "3004722076",
          "3004363352",
          "3007137598",
          "3010864832",
          "2184007",
          "3010326005",
          "3011936016",
          "3005635368",
          "3011580044",
          "2518897",
          "3004989804",
          "3004091527",
          "3002304283",
          "3014945378",
          "1066247",
          "3007457520",
          "3000237660",
          "3009717300",
          "1530958",
          "3003790304",
          "3003895711"
        ],
        "fei_number": [
          "3021023132",
          "3014232530",
          "3018050916",
          "3043648115",
          "3010583458",
          "3003604053",
          "3005205318",
          "3003301977",
          "1643264",
          "3001451571",
          "1000639866",
          "3030516433",
          "3002807616",
          "1000263389",
          "3011215096",
          "3008347129",
          "3004915908",
          "1000080301",
          "3005083075",
          "3009219448",
          "3005439497",
          "3009341091",
          "3004730352",
          "1000115748",
          "2936485",
          "3016527960",
          "1000181430",
          "3007142723",
          "1000582291",
          "3003261709",
          "3011344631",
          "3004158384",
          "3043496873",
          "2916714",
          "3002914049",
          "3009831823",
          "3017697447",
          "3038614464",
          "3001451602",
          "3014991167",
          "3033043422",
          "3004722076",
          "3002806315",
          "3004363352",
          "3007137598",
          "3010862763",
          "3010326005",
          "3011936016",
          "3005635368",
          "3011580044",
          "3004989804",
          "3004091527",
          "3002304283",
          "3014945378",
          "3007457520",
          "3000237660",
          "1000306093",
          "3009717300",
          "3003790304",
          "3001452787",
          "3003895711"
        ],
        "device_name": "Device, Digital Image Storage, Radiological",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.2010",
        "device_class": "1"
      }
    }
  ]
}