{ "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": "190814", "product_res_number": "Z-0492-2022", "event_date_initiated": "2021-12-20", "event_date_created": "2022-01-12", "recall_status": "Open, Classified", "res_event_number": "89218", "product_code": "OWB", "k_numbers": [ "K181670", "K181804", "K182415", "K182546" ], "product_description": "Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.", "code_info": "SID: 30039059, Alphenix System Serial Number: BGC20Y2010, & Flat Panel Detector Serial Number: C1B20Y2215\n\nSID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2218;\n\nSID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2219;\n\nSID: 30046247, Alphenix System Serial Number: B1B20Z2001, & Flat Panel Detector Serial Number: C1B20Z2221;\n\nSID: 30064041, Alphenix System Serial Number: BGD2172011, & Flat Panel Detector Serial Number: C1B2172234;\n\nSID: 30065145, Alphenix System Serial Number: B1E2172002, & Flat Panel Detector Serial Number: C1B2172235;\n\nSID: 30058149, Alphenix System Serial Number: B1E2152001, & Flat Panel Detector Serial Number: C1B2152230;\n\nSID: 30002089, Alphenix System Serial Number: BHC20Z2003, & Flat Panel Detector Serial Number: C1B20Z2217.", "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": "Ms. Terry Schultz\n800-421-1968", "reason_for_recall": "Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient's blood vessel and damage the blood vessel.", "root_cause_description": "Vendor change control", "action": "On 12/21/2021, the firm notified affected customers via a letter titled, \"URGENT: MEDICAL DEVICE CORRECTION.\" The letter indicated, \"Corrective Action: When the new parts become available, your Canon service representative will contact you for an appointment to schedule the installation of the modified x-ray flat panel detector and will install on your system.\n\nRequests to Customers: Should this problem occur before the modified x-ray flat panel detector is installed on your system, please attempt computer reboot, and contact your Canon service representative. \n\nIf you have any questions regarding this matter, please contact your Canon service representative.\n\nPlease share the contents of this letter with all users and reviewing radiologist as well as clinical engineering or biomedical group at your facility.\n\nIn order to comply with the FDA record keeping requirement, Canon respectfully requests that the attached form be completed and returned. Please fax it to the toll free number at the top of the form, or return via email to RAffairs@us.medical.canon. Thank you for your urgent attention to this matter.\"\n\nIf you have any questions regarding this letter please contact the Regulatory Affairs Manager at 800.421.1968 or your Canon service representative at 800.521.1968.", "product_quantity": "8", "distribution_pattern": "US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.", "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", 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