{ "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": 1 } }, "results": [ { "cfres_id": "193875", "product_res_number": "Z-1289-2022", "event_date_initiated": "2022-05-03", "event_date_posted": "2022-06-24", "recall_status": "Open, Classified", "res_event_number": "90246", "product_code": "OWB", "k_numbers": [ "K181804" ], "product_description": "System: Alphenix 4D CT in combination with CAS-930A (C arm Support)\n\nModel Number:\nINFX-8000C/BF,\nINFX-8000C/BH,\nINFX-8000C/SW", "code_info": "UDI-DI Code: 04987670100192\n\nModel Number: INFX-8000C/BF\nSerial Number/SID:\nBFA18Y7001 / 30038795\n\nModel Number: INFX-8000C/BH\nSerial Number / SID:\nBHB2132002 / 30039730\nBHB2132003/ 30039787\nBHA1992001 / 30043325\nBHC21X2004 / Not Provided\n\nModel Number: INFX-8000C/SW\nSerial Numbers/SID:\nSWB2162001 / 30052648", "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": "Gary Becker\n800-421-1968", "reason_for_recall": "CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.", "root_cause_description": "Software design", "action": "On or about 04/20/2022, Canon Medical Systems USA, Inc sent an \"URGENT: MEDICAL DEVICE CORRECTION\" Letter informing customer of a potential issue with your ALPHENIX\nSystem when used in combination with a CT system where the CT operations may be restricted by an interlock which is a result of an error \"H29 M. Net error. The Error message(s) Gantry reached inner limit or Gantry reached out limit may be seen on the CT System at the time of occurence. The CT system may stop operating properly after an attempt to cancel the error message has been initiated. The error may result in the patient needing to be moved to another system for a repeat scan, which could cause a delay in diagnosis or decrease comfort for the patient.\n\nCustomers are being informed that the Recalling Firm has developed a software update that will be installed by a representative of Canon Medical Systems USA that should correct the issue/situation. Prior to the install of the software update, the Urgent customer letter provides a Error resetting (workaround) as follows:\n1. Hold down the Anatomical angle control selection button and the Override\nbutton on the tableside console or the satellite console (option) simultaneously\nfor at least 1 second.\n2. Repeat a second time. This should resolve the error on the CT system.\n\nFor questions, contact Gary Becker, Regulatory Affairs Manager at 800-421-1968 or email gmbecker@us.medical.canon or the Canon Service Representative at 800-521-1968", "product_quantity": "6 systems", "distribution_pattern": "U.S.: CA, CO, FL, NY, and WY\n\nO.U.S.: None", "openfda": { "k_number": [ "K202360", "K260607", "K222080", "K123226", "K251199", "K222998", "K041931", "K202547", "K122644", "K073543", "K220432", "K251827", "K211780", "K022069", "K912448", "K982993", "K101868", "K161839", "K091918", "K070834", "K152697", "K160279", "K231700", "K132970", "K230950", "K243884", "K130638", "K233200", "K052412", "K161563", "K111551", "K153232", "K210054", "K252500", "K152785", "K251992", "K102529", "K122457", "K151904", "K113027", "K172307", "K143281", "K241572", "K220311", "K082781", "K960920", "K123529", "K182415", "K151000", "K212159", "K120073", "K253726", "K052202", "K041932", "K211191", "K251893", "K212523", "K141574", "K212557", 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