{
  "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": "191855",
      "product_res_number": "Z-0723-2022",
      "event_date_initiated": "2022-01-14",
      "event_date_created": "2022-03-04",
      "recall_status": "Open, Classified",
      "res_event_number": "89524",
      "product_code": "OBO",
      "k_numbers": [
        "K181534"
      ],
      "product_description": "CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex",
      "code_info": "All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan",
      "firm_fei_number": "2918630",
      "recalling_firm": "Carl Zeiss Meditec, Inc.",
      "address_1": "5300 Central Parkway",
      "city": "Dublin",
      "state": "CA",
      "postal_code": "94568",
      "additional_info_contact": "925-557-4100",
      "reason_for_recall": "Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.",
      "root_cause_description": "No Marketing Application",
      "action": "On 01/14/22, recall notices were mailed to customers who were asked to do the following:\n\n1. Until further notice, please discontinue the acquisition of the ONH Angiography 4.5x4.5mm Scan.\n2. Using the provided software kit(s), install software version 11.5.3 on all affected instruments. You will be receiving one software kit per affected instrument according to our records. An excerpt of the IFU has been included Section 4.7 Update Instrument Software, these instructions apply to all models. Refer to the IFU Section 4 for the full installation instructions.\n3. Complete and return the Acknowledgement Form per the instructions in the attachment. \nIn case you no longer have the device, we ask that you inform the recalling firm and forward this letter to the new owner.\n\nCustomers with additional questions were encouraged to contact customer service at 1-800-341-6968 (select option 1, 1).",
      "product_quantity": "1,272 devices",
      "distribution_pattern": "U.S Nationwide Distribution.: OH, CA, IN, AR, IA, LA, WI, OK, IL, OR, AL, KY, WY, WA, MN, NE, PA, SD, AZ, PR, TN, GA, FL, DE, NY, NH, TX, MS, MA, NV, UT, WV, ME, CO, AK, NM, KS, MO, MI, MD, ID, CT, NJ, MT, NC, VA, HI, VT, ND, SC, DC, RI",
      "openfda": {
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          "K133217",
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          "K250553",
          "K080460",
          "K101223",
          "K062552",
          "K163195",
          "K181594",
          "K172649",
          "K231673",
          "K241163",
          "K233933",
          "K252633",
          "K221601",
          "K121993",
          "K071839",
          "K192391",
          "K161194",
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          "K221320",
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          "K182569",
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          "K063191",
          "K121043",
          "K163475",
          "K250868",
          "K173119",
          "K230897",
          "K222166",
          "K190732",
          "K113129",
          "K092470",
          "K211817",
          "K161509",
          "K240924"
        ],
        "registration_number": [
          "3013403214",
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          "1054713",
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          "3005950902",
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        ],
        "fei_number": [
          "3013403214",
          "2918630",
          "1000114111",
          "1000582291",
          "4196",
          "3004441848",
          "2242863",
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          "3003481798",
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          "3003768492",
          "1000204638",
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          "3003060634",
          "3005950902",
          "3009746052"
        ],
        "device_name": "Tomography, Optical Coherence",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.1570",
        "device_class": "2"
      }
    }
  ]
}