{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "210844",
      "product_res_number": "Z-0554-2025",
      "event_date_initiated": "2024-10-09",
      "event_date_posted": "2024-11-26",
      "recall_status": "Open, Classified",
      "res_event_number": "95633",
      "product_code": "KIE",
      "product_description": "Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL",
      "code_info": "Model/UDI-DI/Serial Numbers:\nSIL-40C XR CL/04540217420582/L2C316051002, L2C316051003, L2C316051004, L2C316051005, L2C316051006, L2C316051007, L2C316151012, L2C316151013, L2C316151014, L2C316151015.\n\nSIL-40C X3 CL/04540217420575/L2C305850001, L2C305950002, L2C306151025, L2C306051001, L2C306051002, L2C306051003, L2C306051004, L2C306051005, L2C306051007, L2C306051006, L2C306051008, L2C306051009, L2C306051010, L2C306051011, L2C306051012, L2C306051013, L2C306051014, L2C306051015, L2C306151017, L2C306151018, L2C306151022, L2C306151023, L2C306151024, L2C306151026, L2C306151028, L2C306151027, L2C306151029, L2C306151030, L2C306151031, L2C306151032, L2C306151033, L2C306151034, L2C306151035, L2C306151036, L2C306151037, L2C306151038, L2C306151040, L2C306151039.\n\n\nFirmware versions below 1.16.",
      "firm_fei_number": "3010607747",
      "recalling_firm": "Shimadzu Corp. Analytical & Measuring Instruments Div.",
      "address_1": "1 Chome 1 1 Nishinokyokuwabara-Cho",
      "city": "Kyoto",
      "state": "1 Chome",
      "country": "Japan",
      "reason_for_recall": "There have been cases of failure of the main board due to condensation water occurring in the gap between thermal insulation material on the underside of the main base dropping onto the main board The symptoms and errors differ depending on the position where the water drops adhere. To date there have been examples of reports of inter-board communication errors, HOME POSITION error or SLIP error of XYZ drive units. The failure could result in delay of patient sample testing.",
      "root_cause_description": "Device Design",
      "action": "On 10/9/24, field safety notices were mailed to customers asking them to do the following:\n\nCheck the Serial Numbers, and if the instruments are affected by this issue, contact your regional office.\n\nThe corrective actions to be taken to affective products are\n(1) Add a cover part to the main board.\n(2) Update the SIL-40 firmware to Ver. 1.16 or above.\n\nFor questions, please call 800-477-1227 between the hours of 8:30-5:00 EST or visit www.ssi.shimadzu.com.",
      "product_quantity": "48",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of DE, PA and the country of DE.",
      "openfda": {
        "k_number": [
          "K844947",
          "K935666",
          "K800047",
          "K772364",
          "K914841",
          "K911299",
          "K844949",
          "K781771",
          "K800556",
          "K800289",
          "K790145",
          "K800516",
          "K761351",
          "K761219",
          "K781379",
          "K791661",
          "K964588",
          "K800048",
          "K862506",
          "K924347",
          "K782175",
          "K770638",
          "K771156",
          "K781915",
          "K800046"
        ],
        "registration_number": [
          "2916205",
          "3006397327",
          "1218959",
          "3001040364",
          "3008336863",
          "3009715051",
          "3010607747",
          "3003809634",
          "3009202467",
          "3003423869"
        ],
        "fei_number": [
          "2916205",
          "3006397327",
          "1218959",
          "3001040364",
          "3008336863",
          "3009715051",
          "3010607747",
          "3003809634",
          "3009202467",
          "3003423869"
        ],
        "device_name": "Apparatus, High Pressure Liquid Chromatography",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2260",
        "device_class": "1"
      }
    }
  ]
}