{
  "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": "190716",
      "product_res_number": "Z-0478-2022",
      "event_date_initiated": "2021-11-03",
      "event_date_created": "2022-01-10",
      "recall_status": "Open, Classified",
      "res_event_number": "89176",
      "product_code": "OBO",
      "k_numbers": [
        "K142953"
      ],
      "product_description": "OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4",
      "code_info": "Serial no. 0157, 0158 & 0171",
      "firm_fei_number": "1000136533",
      "recalling_firm": "Haag-Streit USA Inc",
      "address_1": "3535 Kings Mills Rd",
      "city": "Mason",
      "state": "OH",
      "postal_code": "45040-2303",
      "additional_info_contact": "Mike Dietz\n513-486-1513",
      "reason_for_recall": "Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off",
      "root_cause_description": "Software design (manufacturing process)",
      "action": "Haag-Streit USA send out field safety notice 2021-10/01 on November 03, 2021.\n\nActions to be taken by the customer/user:\nShould one or more continuous straight lines be displayed on the screen of the OCT camera during an operation on the posterior segment of the patient's eye (see picture in the notification), the described risk possibly exists.\n\n1. Switch off the OCT camera immediately (menu OCT -> Switch off).\n2. The OCT camera is not permitted to be used any more. Please contact your\nresponsible country representative.\n3. Perform the software update of the OCT camera. You will receive the new software\nversion via your local representative, who will correct the error.\n4. Please fill out and return the enclosed response form as soon as the software\nupdate has been performed\n5. Please ensure that all users of the products mentioned are aware of and receive this urgent safety information. If you have passed the products to third parties, please forward a copy of this information and inform the contact person listed in the notification.\n6. Software update organization will be performed by Haag-Streit USA, Inc. Please contact Mike Dietz at (513) 486-1513 or via email: fieldsafetynotice@haag-streit-usa.com for questions concerning this procedure.",
      "product_quantity": "3",
      "distribution_pattern": "US Nationwide distribution in the states of OH, IN.",
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        "device_name": "Tomography, Optical Coherence",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.1570",
        "device_class": "2"
      }
    }
  ]
}