{ "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": "55428", "product_res_number": "Z-0056-2008", "event_date_initiated": "2007-08-24", "event_date_posted": "2007-10-13", "recall_status": "Terminated", "event_date_terminated": "2010-08-17", "res_event_number": "39408", "product_code": "DXT", "k_numbers": [ "K963071" ], "product_description": "Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO.", "code_info": "Product Model Numbers : 902040; 904045; and 902045CI", "firm_fei_number": "1518293", "recalling_firm": "Mallinckrodt Inc", "address_1": "2111 E Galbraith Rd", "city": "Cincinnati", "state": "OH", "postal_code": "45237-1624", "additional_info_contact": "513-948-5719", "reason_for_recall": "Synchronization problems: units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit's main console and the unit's auxiliary consoles, mis-synchronization could occur resulting in a variance between the intended injection parameters (those programmed) and the actual parameters of the injection deliv", "root_cause_description": "Device Design", "action": "On 9/20/2007, a notification was sent from Mallinckrodt to all direct accounts via certified mail. The notification details the potential for mis-synchronization of injection parameters if the main and auxiliary consoles are simultaneously programmed. The notification reminds end-users that simultaneous programming should not be performed and to ensure it is not performed, a notification label (provided in the notification) is to be affixed on both consoles of the injector system. Once the label is affixed to the system, end-users are instructed to complete the notification survey and return the survey to the Mallinckrodt. In addition, the notification includes an updated chapter insert (Chapter 11.1) for the injector system's product manual that emphasize the separation between programming of the main and auxiliary consoles. Questions regarding this matter may be directed to Mallinckrodt's Product Monitoring Department at 1-888-744-1414, menu option 1 and then menu option 2.", "product_quantity": "176", "distribution_pattern": "Worldwide to include:U.S.A. states of - AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, & WI. and Foreign countries of Argentina, Belgium, Brazil, Canada, Germany, Japan, Singapore, & Zambia.", "openfda": { "k_number": [ "K182273", "K863537", "K911166", "K905819", "K033247", "K863596", "K934086", "K023183", "K182289", "K113133", "K020892", "K062168", "K000013", "K203004", "K140469", "K904212", "K061976", "K072886", "K170431", "K163084", "K844045", "K171698", "K873597", "K924116", "K140425", "K890292", "K910873", "K984088", "K875324", "K912944", "K142081", "K833138", "K142745", "K232388", "K012950", "K873410", "K911549", "K964642", "K823253", "K973230", "K051799", "K090621", "K092896", "K133189", "K171646", 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