{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "220078",
      "product_res_number": "Z-2294-2026",
      "event_date_initiated": "2026-04-20",
      "event_date_posted": "2026-06-02",
      "recall_status": "Open, Classified",
      "res_event_number": "98571",
      "product_code": "OWB",
      "k_numbers": [
        "K062360",
        "K123508",
        "K152244",
        "K203535",
        "K221922",
        "K233722"
      ],
      "product_description": "Digital Angiography System Trinias:UD150G-40 / D150GC-40;\nDigital Angiography System BRANSIST safire:UD150G-40 / D150GC-40;\nDigital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40;\nDigital Radiography System RADspeed Pro: UD150B-40 / UD150V-40 / UD150L-40 / UD150L-40E/D150BC-40 / D150VC-40 / D150LC-40 / D150LC-40E/D150BC-41 / D150VC-41 / D150LC-41;\nDigital Radiography System RADspeed safire: UD150B-40 / D150BC-40;\nRadiography System RADspeed fit: N/A (Integrated in the system);\nX-RAY R/F SYSTEM SONIALVISION safire17:UD150B-40 / D150BC-40;\nX-RAY R/F SYSTEM SONIALVISION safire Plus: UD150B-40 / D150BC-4;0\nX-RAY R/F SYSTEM SONIALVISION safire: UD150B-40 / D150BC-40;\nX-RAY R/F SYSTEM SONIALVISION VERSA: UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40;\nX-RAY R/F SYSTEM FLUOROspeed 300:UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40;\nX-RAY R/F SYSTEM SONIALVISION G4:D150BC-40S;\nX-RAY R/F SYSTEM FLUOROspeed X1:D150BC-40S",
      "code_info": "System Serial 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\n\nGenerator Serial Numbers: 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      "firm_fei_number": "1000125362",
      "recalling_firm": "Shimadzu Medical Systems",
      "address_1": "3645 N Lakewood Blvd",
      "city": "Long Beach",
      "state": "CA",
      "postal_code": "90808-1797",
      "additional_info_contact": "Mr. Joseph Zegarelli\n310-217-8855 Ext. 117",
      "reason_for_recall": "Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.",
      "root_cause_description": "Component design/selection",
      "action": "On April 20, 2026 Shimadzu Medical Systems USA issued a Urgent: Voluntary Medical Device Recall Notification via E-Mail. Shimadzu asked consignees to take the following actions: \n\n1. If your site is on the applicable list, please schedule time with your Distributer to have your system updated.\n\n2. Shimadzu requests that you post this letter within your facility so that all users are aware of how to avoid this issue until the corrective actions have been completed.\n\n3. If there are any issues, please report them to your respected distributor.\n\n4. Please complete the acknowledgement form below.\n\n5. For additional safety measures, please see customer notification.",
      "product_quantity": "3487 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, The Bahamas, China, Denmark, Haiti.",
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