{ "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": 2 } }, "results": [ { "cfres_id": "194432", "product_res_number": "Z-1331-2022", "event_date_initiated": "2021-05-05", "event_date_posted": "2022-07-05", "recall_status": "Open, Classified", "res_event_number": "90446", "product_code": "KPR", "k_numbers": [ "K140683" ], "product_description": "Omnera 400T Digital Radiographic System", "code_info": "UDI/DI:07350008750050; 2001-2003, 2006-2044, 2046-2056, 2118-2126, 2128-2131, 2134-2160, 2164-2175, 2177-2195, 2197-2208, 2210-2212, 2214-2224, 2226-2236.", "firm_fei_number": "3002675731", "recalling_firm": "Arcoma AB", "address_1": "Annavagen 1 1 annavagen", "city": "Vaxjo", "country": "Sweden", "additional_info_contact": "Gary Becker\n800-4211968", "reason_for_recall": "There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).", "root_cause_description": "Device Design", "action": "On May 7, 2021, Arcoma issued a \"Urgent Field Safety Notice\". The recall notice asked consignees to take the following actions:\n\nIdentify the device\n\nTake note of amendment/reinforcement of Instructions of Use (IFU) and replace all pages in the Cleaning and disinfection chapter with pages in FSN_2021_01_IFU-EN Rev. 1.1. \n\nOn May 23, 2022, Arcoma issued a Safety Advisory Notice/ Field Safety Notice via E-Mail informing consignees that they would be updating the display handle with the updated version as an additional safety precaution. \n\nArcoma has requested that Canon Medical System, USA ensure that all those who have the affected product, including any others who may need to be informed, receive the safety relevant information provided with this notice and comply with the recommendations herein. A representative of Canon Medical System USA will contact you to schedule a time to replace the display handle with the updated version.", "product_quantity": "71 systems", "distribution_pattern": "US Nationwide distribution in the states of NM, DE, TX, VT, FL, MO, UT, PA, OR, IN, RI, MI, IL, LA, OH, CO, SC, VA, WA, CA, AZ, NV, AR and the country of Canada.", "openfda": { "k_number": [ "K182134", "K231892", "K810973", "K250954", "K133959", "K140334", "K913659", "K934755", "K080614", "K190601", "K070678", "K080582", "K841756", "K973219", "K810797", "K233662", "K192453", "K202572", "K091889", "K213700", "K900562", "K122726", "K230800", "K972000", "K945278", "K202293", "K173828", "K982824", "K233722", "K781613", "K920558", "K920347", "K193089", "K101435", "K193225", "K023008", "K921539", "K063246", "K934005", "K203537", "K193574", "K133259", "K870300", "K242678", "K152767", "K872525", "K915362", "K182622", "K172869", "K193637", "K173517", "K260482", "K214012", "K011486", "K950980", 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