{
  "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": {
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  "results": [
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      "cfres_id": "84748",
      "product_res_number": "Z-0160-2010",
      "event_date_initiated": "2009-08-03",
      "event_date_posted": "2009-11-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-01-26",
      "res_event_number": "53134",
      "product_code": "LMB",
      "product_description": "Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad)\n\nIntended use of Guardian Services is to act as a medical data backup and disaster recovery plan.",
      "code_info": "All accounts that have OrthoPad and are signed up for 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": "Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis.",
      "root_cause_description": "Other",
      "action": "Firm notified consignees by an Urgent: Device Correction letter, dated 7/31/2009.  The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem.  The letter also states the firm's recommendations to reduce risk to patients.  Stryker will not bill customers for the Guardian service until the problem is remediated and the firm notifies customers.  If there are any questions, customers are to contact the firm at 972-410-7100.",
      "product_quantity": "85",
      "distribution_pattern": "Nationwide Distribution",
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        "device_name": "Device, Digital Image Storage, Radiological",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.2010",
        "device_class": "1"
      }
    }
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}