{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "188670", "product_res_number": "Z-2453-2021", "event_date_initiated": "2021-06-21", "event_date_created": "2021-09-13", "recall_status": "Open, Classified", "res_event_number": "88441", "product_code": "INM", "product_description": "Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers:\n10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21.\n\nModel Number: CHAIR-0-SC2-030; Advance Chair, 100mm (4in) Castors, Std Backrest, Electric; Serial Numbers: 10001-SC2-20 to 10135-SC2-20; 10001-SC2-21 to 10240-SC2-21.\n\nModel Number: CHAIR-0-SC3-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard\nBackrest, Manual; Serial Numbers: 10116-SC3-20 to 10145-SC3-20; 10236-SC3-20 to 10295-SC3-20; 10001-SC3-21 to 10090-SC3-21; 10271-SC3-21 to 10360-SC3-21; 10001-SC3-20 to 10115-SC3-20; 10146-SC3-20 to 10235-SC3-20.\n\nModel Number: CHAIR-0-SC4-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard\nBackrest, Electric; Serial Numbers: 10001-SC4-20 to 10030-SC4-20.", "code_info": "Serial Numbers (Domestically distributed) 10001-SC3-20 to 10115-SC3-20\n10146-SC3-20 to 10235-SC3-20", "firm_fei_number": "3013254491", "recalling_firm": "Accora Inc", "address_1": "9210 Corporate Blvd Ste 120 9210 Corporate Blvd", "address_2": "Ste 120", "city": "Rockville", "state": "MD", "postal_code": "20850-6226", "reason_for_recall": "The firm has identified a potential for the backrest to become detached from the chair.", "root_cause_description": "Device Design", "action": "On June 21, 2021, the firm sent affected customers Urgent Field Safety Notices via email. The notice identified the affected products and informed customers of the product issue. The corrective action will be to fit a modification kit to eliminate this fault condition and ensure the backrest cannot detach from the chair. All new production chairs will have this kit fitted as standard.\n\nCustomers should make sure that all caregivers and users of the affected Configura Advance Chair devices are made aware of this Field Safety Notice. Furthermore, they should contact Accora to arrange a Field Safety Corrective Action kit to be installed on each product. This will be fitted free of charge.\n\nIf you have questions or require assistance, please contact Accora:\n\n\nAccora Limited, Charter House, Barrington Road, Orwell, Cambridge SG8 5QP\nT: +44 (0)1223 206100 E: info@accora.care", "product_quantity": "122 (US); 270 (OUS)", "distribution_pattern": "Worldwide distribution - US Nationwide in the states of AL, FL, IL, MN, MS, NH, NJ, NY, NC, OH, PA, SC and the countries of Ireland, UK, and Australia.", "openfda": { "device_name": "Chair, With Casters", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.3100", "device_class": "1", "k_number": [ "K924848", "K941738", "K840638", "K933000", "K841700", "K851550", "K851548", "K926025", "K921752", "K926053", "K830850", "K926028", "K862886", "K921917", "K941569", "K895165", "K823151", "K781001", "K841911", "K820858", "K802745", "K841194", "K925247", "K822992", "K913544", "K883309", "K063521", "K922045", "K841725", "K790560", "K926054", "K921817", "K884760", "K880986", 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