{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "188895", "product_res_number": "Z-2593-2021", "event_date_initiated": "2021-08-02", "event_date_created": "2021-09-29", "recall_status": "Open, Classified", "res_event_number": "88521", "product_code": "KPS", "k_numbers": [ "K182237", "K193241" ], "product_description": "uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.", "code_info": "Model: 88000057\nGTIN/UDI Codes:\n06971576832026\t/ 01\t06971576832026 240\t88000057 21\t200017\n06971576832026\t/ 01\t06971576832026 240\t88000057 21\t200023\n06971576832026\t/ 01\t06971576832026 240\t88000057 21\t200024\n06971576832026\t/ 01\t06971576832026 240\t88000057 21\t200036\n06971576832026\t/ 01\t06971576832026 240\t88000057 21\t200045\n06971576832026\t/ 01\t06971576832026 240\t88000057 21\t200047\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230002\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230003\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230004\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t200059\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230005\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230006\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230007\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230008\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230009\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230010\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230011\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230012\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230013\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230014\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230015\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230016\n06971576832057\t/ 01\t06971576832057 240\t88000057 21\t230017\n\nSerial Numbers:\n200017;\n200023;\n200024;\n200036;\n200045;\n200047;\n230002;\n230003;\n230004;\n200059;\n230005;\n230006;\n230007;\n230008;\n230009;\n230010;\n230011;\n230012;\n230013;\n230014;\n230015;\n230016;\n230017;", "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": "The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.", "root_cause_description": "Device Design", "action": "On 08/02/2021, the Firm emailed to its customer an \"Advisory Notification\" informing them of a potential safety-relevant issue in which the EXAM acquisition workflow could occasionally freeze after canceling the PET scan. The issue and the sequence of events leading to this occurrence are as follow:\nDuring a myocardial perfusion scan procedure, the follow steps could lead to the EXAM acquisition workflow to occasionally freeze-\n1. Selecting the myocardial perfusion scan procedure and entering EXAM.\n2. Finishing the CT scout and helical/cine scan.\n3. Starting the PET scan.\n4. Canceling the current PET scan -- in this case the EXAM acquisition workflow may shut down, resulting in an error message stating: \"EXAM (Study ID: XXXXXXX) has some errors, trying to restart. Please wait and try again.\n5. Reentering the EXAM acquisition workflow without restarting the system, and then attempting to continue the scan.\nIf the above occurs, this may require rescanning of the patient, resulting in additional CT dose exposure.\n\nCustomer are instructed to:\n1. When the EXAM acquisition workflow is interrupted after cancellation of the scan, follow the steps to resume the procedure:\na) Wait until CT reconstruction finishes.\nb) Perform a system restart.\nc) After restart, select the suspended procedure on the patient administration (PA) interface and enter EXAM. System will load and recover the status of this procedure.\nd) Duplicate or copy and paste the unfinished PET scan, and then continue.\n2. Please notify all internal users of the PET/CT system, using this letter.\n3. Complete and sign the Receipt of Advisory Notification Form and return it to the Recalling Firm via fax, email or mail.\n\nThe Recalling Firm is working on releasing a software update to resolve this issue. Planned release of software update is Q4 of 2021.\n\nFor questions, contact the Recalling Firm's service engineer or call the customer contact center's 24 hour hotline at (855)221-1552 (toll free) or (832)699-2799 (d", "product_quantity": "23 systems", "distribution_pattern": "U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.", "openfda": { "k_number": [ "K140269", "K171681", "K110507", "K942860", "K062393", "K980867", "K192277", "K260524", "K983948", "K091269", "K041220", "K033956", "K003264", "K892358", "K032779", "K033782", "K191582", "K021656", "K123737", "K850416", "K022960", "K181468", "K202882", "K000908", "K014033", "K051460", "K802801", "K182484", "K961577", "K081135", "K243186", "K991565", "K894998", "K080784", "K001681", "K002715", "K042258", "K964712", "K915644", "K152880", "K103710", "K090178", "K923309", "K130269", "K992335", "K914807", "K912176", "K032866", "K221932", "K212004", "K945652", "K210262", "K060486", "K171719", "K922080", "K922427", 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"medical_specialty_description": "Radiology", "regulation_number": "892.1200", "device_class": "2" } } ] }