{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "218457",
      "product_res_number": "Z-1494-2026",
      "event_date_initiated": "2026-01-08",
      "event_date_posted": "2026-03-05",
      "recall_status": "Open, Classified",
      "res_event_number": "98360",
      "product_code": "FEO",
      "k_numbers": [
        "K171024"
      ],
      "product_description": "Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator\nProduct Name: ShockPulse-SE Lithotripsy System - Reuseable Probes\nModel/Catalog Number: SPL-SR, contains generator SPL-G\nProduct Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.",
      "code_info": "Model/Catalog Number: SPL-SR, contains generator SPL-G;\nUDI:  SPL-SR 00821925043824, SPL-G 00821925044203;\nSerial Numbers: CG5026, CG5027, CG5028, CG5029, CG5030, CG5031, CG5032, CG5033, CG5034, CG5035, CG5036, CG5037, CG5039, CG5040, CG5041, CG5042, CG5043, CG5045, CG5046, CG5047, CG5048, CG5049, CG5050, CG5051, CG5052, CG5053, CG5054, CG5055, CG5056, CG5057, CG5058, CG5059, CG5060, CG5061, CG5062, CG5063, CG5065, CG5066, CG5067, CG6037, CG6061, CG6069, CG6070, CG6071, CG6088, CG6094, CG6095, CG6096, CG6097, CG6098, CG6099, CG7000, CG7001, CG7002, CG7003;",
      "firm_fei_number": "2429304",
      "recalling_firm": "Olympus Corporation of the Americas",
      "address_1": "3500 Corporate Pkwy",
      "city": "Center Valley",
      "state": "PA",
      "postal_code": "18034-8229",
      "additional_info_contact": "Cynthia Ow\n647-9993203",
      "reason_for_recall": "Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.",
      "root_cause_description": "Device Design",
      "action": "On January 8, 2026, URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. \nActions to be taken:\n1. Examine your inventory and identify any affected devices.\n2. Contact your Olympus Customer Service contact to obtain a Return Material Authorization and arrange for the return of your device. Olympus will repair the affected part at no charge and return the device back to you.\n3. If you have further distributed the affected products, please forward this notification to other users who may have them.\nOlympus requests you to report any complaints related to the ShockPulse device to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.",
      "product_quantity": "55 units (All OUS)",
      "distribution_pattern": "International distribution in the country of Canada, Germany, Singapore, Australia, and India.",
      "openfda": {
        "k_number": [
          "K181997",
          "K142428",
          "K171024",
          "K181364",
          "K173234",
          "K850298",
          "K920235",
          "K993046",
          "K973251",
          "K182490",
          "K843101",
          "K842024",
          "K230893",
          "K873367"
        ],
        "registration_number": [
          "3004096429",
          "3006617533",
          "3010202439",
          "3010707607",
          "3014342096",
          "3003790304",
          "1648564",
          "3006546082",
          "3009420598",
          "9614434",
          "3024021261",
          "2020550",
          "1220477",
          "1519132",
          "3011050570",
          "2244478",
          "2528981",
          "9611102",
          "8030987",
          "2183744",
          "9610617",
          "2435119"
        ],
        "fei_number": [
          "3004096429",
          "3007475226",
          "1000136269",
          "3006617533",
          "3010707607",
          "3014342096",
          "3003790304",
          "3000205943",
          "3006546082",
          "3009420598",
          "3024021261",
          "2020550",
          "1220477",
          "1519132",
          "3002808273",
          "3011050570",
          "2528981",
          "3002806910",
          "2183744",
          "3002808268",
          "2435119",
          "3002808001"
        ],
        "device_name": "Lithotriptor, Ultrasonic",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4480",
        "device_class": "2"
      }
    }
  ]
}