{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "180488", "product_res_number": "Z-2325-2020", "event_date_initiated": "2020-03-03", "event_date_created": "2020-06-09", "recall_status": "Open, Classified", "res_event_number": "85309", "product_code": "OWB", "k_numbers": [ "K170909" ], "product_description": "Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional 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": "Serial Numbers: A5B1642006, A1B17X2004, A5A1612005, A5B1772009, B5B1962002, A3A1522004, A7B16Y2001, A3A1712011, A5B1792010, A5A1532002, A1A1612003, A3A15Z2007, A5A1552003, A5B16Y2007, A3B1862016, A3B1812013, A3A1662009, A9A16X2004, BTA1922001, A3B1842015, AOB1882001, BMB1942001, AOB1892002, A5B1472001, A5B17Z2011, A3A14X2002, A5A1592004, A3A17Z2012, A5C1832012, A5B16Z2008, A1A1582002, A9A1582002, A1A14X2001, A3A1512003, A7C1812002, ABC18X2002, A3A1592005, UTC14Y2008, A3A15X2006, B5B1942001, A3A1682010, A1C18Z2005, A9A1662003, A3A1492001, A3B1822014, A3A1622008", "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": "714-730-5000", "reason_for_recall": "Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.", "root_cause_description": "Process control", "action": "On 03/03/20, Urgent Medical Device Correction notices were mailed to Radiology Managers/Directors. To correct this issue, the bolts holding the longitudinal movement of the table will need to be inspected to determine if the bolts are tightened to specification. Recalling firm service representatives will contact customers to set up appointments to inspect bolts. Radiology Managers/Directors were advised of the following:\n\na) Should this problem occur before your appointment with the recalling firm's service representative, please stop using the system and contact the service representative.\nb) If abnormalities are found operating the table during a procedure, please stop use, and contact the service representative.\nc) Share this information with all users and reviewing radiologists as well as clinical engineering, and the biomedical group at your facility.\nd) Complete and return the Customer Reply Form.\n\nAdditional questions should be directed to (800) 421-1968 or your local service representative (800) 521-1968", "product_quantity": "46", "distribution_pattern": "US Nationwide distribution including in the states of PA, AR, OH, NC, CA, IA, GA, IL, AL, WV, LA, MO, FL, MS, TX, AZ, MA, NJ, MD, NY, NV, OK, WI, PR.", "openfda": { "k_number": [ "K253584", "K170752", "K170144", "K192182", "K170909", "K142126", "K970734", "K052412", "K180473", 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"device_class": "2" } } ] }