{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "177385", "product_res_number": "Z-0360-2020", "event_date_initiated": "2019-02-08", "event_date_created": "2019-11-12", "recall_status": "Terminated", "event_date_terminated": "2022-06-07", "res_event_number": "84135", "product_code": "MQB", "k_numbers": [ "K081624" ], "product_description": "Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.", "code_info": "Model CAT-870B D053991  Serial No. Manufacture Date 99D08X2101 October 2008 99D0582039 August 2005 99D0762072 June 2007 99D0852090 May 2008 99D07Y2078 November 2007 99D0812081 January 2008 99D0582042 August 2005 99D0552033 May 2005 D551206 May 2005", "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": "Terry Schultz\n714-669-4121", "reason_for_recall": "Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.", "root_cause_description": "Error in labeling", "action": "On 02/08/2019, the firm sent an \"URGENT: MEDICAL DEVICE CORRECTION\" Notification to customers via USPS return receipt mail informing them of the potential problem with the Catheterization Table (CAT-870B) may tilt without operator involvement due to accidental liquid spillage. Customers are instructed to:\na. Please keep the tableside console and the x-ray detector of the support units covered with sterile caps as stated in the Caution section of the operation manual. The caps are there to prevent liquids from coming into contact with the tableside console and the x-ray detector.\nb. If an actual event occurs, please push the emergency switch and call your service representative.\nc. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility.\nd. Please complete and return the attached form and fax it to the toll free number 877-349-3054. This form may also be sent via email to RAffairs@us.medical.canon.\n\nIf customers have any questions regarding this letter, they are free to contact Regulatory Affairs Manager at (800) 421-1968 or their local\nRepresentative at (800) 521-1968.", "product_quantity": "9 systems", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, CT, FL, IL, OR, PA, and TX; and country of Netherlands.", "openfda": { "k_number": [ "K052136", "K140060", "K160143", "K042041", "K051418", "K102619", "K072983", "K201058", "K091090", "K191645", "K182348", "K131408", "K151221", "K201247", "K162504", "K093427", "K121095", "K151014", "K982795", "K182551", "K103591", "K141736", "K180332", "K183286", "K190611", "K992955", "K193017", "K162178", "K153401", "K152094", "K050810", "K193173", "K221549", "K231709", "K031198", "K183212", "K242394", "K213307", "K240371", "K073670", "K192512", "K141271", "K252911", "K133693", "K110801", "K161966", "K130377", "K230918", 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