{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "199081", "product_res_number": "Z-1353-2023", "event_date_initiated": "2023-03-01", "event_date_posted": "2023-04-07", "recall_status": "Open, Classified", "res_event_number": "91870", "product_code": "KPS", "k_numbers": [ "K182237", "K193241" ], "product_description": "Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550\nPart Number:\n88000657\n88000057", "code_info": "Models: 88000657\nSerial Number/UDI Code:\n230003 /\t 01\t06971576832057 240\t88000657 21\t230003\n230005 /\t 01\t06971576832057 240\t88000657 21\t230005\n230007 /\t 01\t06971576832057 240\t88000657 21\t230007\n230012 /\t 01\t06971576832057 240\t88000657 21\t230012\n230013 /\t 01\t06971576832057 240\t88000657 21\t230013\n230014 /\t 01\t06971576832057 240\t88000657 21\t230014\n230015 /\t 01\t06971576832057 240\t88000657 21\t230015\n230016 /\t 01\t06971576832057 240\t88000657 21\t230016\n230017 /\t 01\t06971576832057 240\t88000657 21\t230017\n230020 /\t 01\t06971576832057 240\t88000657 21\t230020\n230021 /\t 01\t06971576832057 240\t88000657 21\t230021\n230022 /\t 01\t06971576832057 240\t88000657 21\t230022\n230023 /\t 01\t06971576832057 240\t88000657 21\t230023\n230024 /\t 01\t06971576832057 240\t88000657 21\t230024\n230026 /\t 01\t06971576832057 240\t88000657 21\t230026\n230027 /\t 01\t06971576832057 240\t88000657 21\t230027\n230028 /\t 01\t06971576832057 240\t88000657 21\t230028\n230029 /\t 01\t06971576832057 240\t88000657 21\t230029\n230030 /\t 01\t06971576832057 240\t88000657 21\t230030\n230031 /\t 01\t06971576832057 240\t88000657 21\t230031\n230032 /\t 01\t06971576832057 240\t88000657 21\t230032\n230033 /\t 01\t06971576832057 240\t88000657 21\t230033\n230035 /\t 01\t06971576832057 240\t88000657 21\t230035\n230036 /\t 01\t06971576832057 240\t88000657 21\t230036\n230037 /\t 01\t06971576832057 240\t88000657 21\t230037\n230038 /\t 01\t06971576832057 240\t88000657 21\t230038\n230039 /\t 01\t06971576832057 240\t88000657 21\t230039\n230040 /\t 01\t06971576832057 240\t88000657 21\t230040\n230041 /\t 01\t06971576832057 240\t88000657 21\t230041\n230042 /\t 01\t06971576832057 240\t88000657 21\t230042\n230043 /\t 01\t06971576832057 240\t88000657 21\t230043\n230044 /\t 01\t06971576832057 240\t88000657 21\t230044\n230045 /\t 01\t06971576832057 240\t88000657 21\t230045\n230047 /\t 01\t06971576832057 240\t88000657 21\t230047\n230048 /\t 01\t06971576832057 240\t88000657 21\t230048\n\nModel Number: 88000057\nSerial Number/UDI Code:\n200017 /\t 01\t06971576832026 240\t88000057 21\t200017\n200023 /\t 01\t06971576832026 240\t88000057 21\t200023\n200024 /\t 01\t06971576832026 240\t88000057 21\t200024\n200036 /\t 01\t06971576832026 240\t88000057 21\t200036\n200045 /\t 01\t06971576832026 240\t88000057 21\t200045\n200047 /\t 01\t06971576832026 240\t88000057 21\t200047\n200059 /\t 01\t06971576832026 240\t88000057 21\t200059\n200071 /\t 01\t06971576832026 240\t88000057 21\t200071\n200072 /\t 01\t06971576832026 240\t88000057 21\t200072\n200075 /\t 01\t06971576832026 240\t88000057 21\t200075\n200078 /\t 01\t06971576832026 240\t88000057 21\t200078\n200079 /\t 01\t06971576832026 240\t88000057 21\t200079", "firm_fei_number": "3011015597", "recalling_firm": "Shanghai United Imaging Healthcare Co., Ltd.", "address_1": "No. 2258 Chengbei Rd, Jiading Ind. Chengbei Rd", "address_2": "No. 2258", "city": "Shanghai", "country": "China", "reason_for_recall": "Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.", "root_cause_description": "Software design", "action": "On 03/01/2023, the firm sent an \"Advisory Notification: Positron Emission Tomography and Computed Tomography System (PET/CT)\" Letter via email to customers informing them that, the scatter correction may fail due to GPU (Graphic Processing Unit) memory access exception. The failure of the scatter correction could result in the failure of the PET image reconstruction.\n\nCustomers are instructed to:\n1. if the default PET image reconstruction fails with an error information of abnormal GPU status, but the reconstruction without either attenuation correction or scatter correction works successfully, the following actions are suggested to be applied:\n1) Try using the diagnostic CT image series instead of ACCT image series for attenuation correction to repeat the PET reconstruction. It may resolve the error issue, but the quantification of PET image might be affected due to attenuation correction with using the limited field of view of diagnostic CT image. If the resulted PET image is insufficient for diagnosis, try second suggestion.\n2) Try re-perform the PET acquisition, the reconstruction may succeed.\n3) Contact the United Imaging service engineer to install the updated software to resolve the issue, and offline reconstruct the PET image.\n\nFor questions, contact United Imaging service engineer or call the United Imaging Customer Contact Center (24- hour hotline) at 855-221-1552 (toll-free) or 832-699-2799 (direct).", "product_quantity": "47 systems (U.S. only)", "distribution_pattern": "U.S. Nationwide distribution in the state of TX.\n\nO.U.S.: Not provided.", "openfda": { "k_number": [ "K180318", "K182484", "K925186", "K922303", "K193248", "K861252", "K011572", "K210262", "K922426", "K982911", "K101768", "K090811", "K926133", "K082581", "K031874", "K931193", "K042880", "K261427", "K051460", "K161631", "K072307", "K020300", "K033001", "K133657", "K001276", "K193241", "K062298", "K083649", "K931297", "K932745", "K915470", 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