{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221087", "product_res_number": "Z-3014-2026", "event_date_initiated": "2026-08-04", "event_date_posted": "2026-08-25", "recall_status": "Open, Classified", "res_event_number": "99222", "product_code": "OWB", "k_numbers": [ "K182415", "K203551", "K210900" ], "product_description": "Alphenix Models\nINFX-8000C\nINFX-8000F\nINFX-8000V\n\nThis device is a digital radiography/fluoroscopy system used in a diagnostic and\ninterventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.", "code_info": "Model Number: INFX-8000C/B3\nUDI code: Pending\nSID Number:30101165 \nSerial Number: B3E2422005\n\n\nModel Number: INFX-8000F/SG\nUDI code: Pending\nSID Number: 30093711\nSerial Number: SGC2412001\n\nModel Number: INFX-8000V/SZ\nUDI code: Pending\nSID Number: 30029686 Serial Number: SZA2422001\nSID Number: 79000002 Serial Number:SZA2442004 \n\nModel Number: INFX-8000V/SX\nUDI code: Pending\nSID Number: 30049491 Serial Number: SXA2432001\nSID Number: 30100053 Serial Number: SXA2432002\n\nModel Number: INFX-8000V/B9\nUDI code: Pending\nSID Number: 30059175\nSerial Number: B9F2412001\n\nModel Number: INFX-8000V/ST\nUDI code: Pending\nSID Number: 30059180\nSerial Number: STA2412001\n\nModel Number: INFX-8000V/SZ\nUDI code: Pending\nSID Number: 30095017 Serial Number: SZA2432003\nSID Number: 30097052 Serial Number: SZA2422002", "firm_fei_number": "2020563", "recalling_firm": "Canon Medical System, USA, INC.", "address_1": "2441 Michelle Dr", "city": "Tustin", "state": "CA", "postal_code": "92780-7047", "additional_info_contact": "Orlando Tadeo\n714-483-1551", "reason_for_recall": "Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.", "root_cause_description": "Process control", "action": "On 08/04/2026, an \"URGENT: MEDICAL DEVICE CORRECTION\" letter was sent via email informing customers that, It has been found there is a possibility that the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. Indications that the screws have loosened are abnormal noises and sensor errors from the ceiling mounted C-arm.\n\nCustomers are instructed to:\nShould the suspended device make an abnormal noise, or a sensor error is displayed before the corrective action is implemented on your system, please stop using the device and call your local Canon Service Team.\nAdditionally, it is strongly requested that you share the contents of this letter with all users as well as clinical engineering or biomedical group at your facility.\n\nA representative of Canon Medical Systems USA will contact customers to schedule a time to check for the tightening and proper attachment of the fixing screws to correct this issue your system(s).\n\nFor Questions - contact your service representative contact the InTouch team at intouchdispatch@us.medical.canon.", "product_quantity": "10 systems", "distribution_pattern": "U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.", "openfda": { 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"Interventional Fluoroscopic X-Ray System", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ] }