{ "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": "90505", "product_res_number": "Z-0332-2011", "event_date_initiated": "2010-03-05", "event_date_posted": "2010-11-09", "recall_status": "Terminated", "event_date_terminated": "2014-10-06", "res_event_number": "55301", "product_code": "FNL", "product_description": "Excel Care Bariatric Bed, P 610A, Hill-Rom, Batesville, IN. \n\nIntended Use: The Excel Care Bariatric Bed is for bariatric patients with varying medical and physical conditions. The bed supports patients between 250 and 1000 pounds.", "code_info": "XL100092, \tXL100091, XL100077, \tXL100124 and XL101363.", "firm_fei_number": "1824206", "recalling_firm": "Hill-Rom, Inc.", "address_1": "125 E Pearl St 1069 State Route 46 East", "city": "Batesville", "state": "IN", "postal_code": "47006", "additional_info_contact": "812-934-7777", "reason_for_recall": "The firm received complaints regarding the siderails not operating correctly or becoming inoperable. The siderails could experience false latching, unintentional lowering or become inoperable. There have been reports of 5 patient falls and 2 injuries to caregivers.", "root_cause_description": "Device Design", "action": "Hill-Rom sent out \"Urgent Medical Device Correction\" letters dated March 5, 2010. The letters described the product, problem and actions to be taken by the customers. The letters instructed the customers to locate the beds and examine the siderails for any visible damage (cracks, bending, loose parts) and conduct a physical assessment of all four siderails on each bed to determine if the sideral could be placed in all positions. If the siderails were found to be inoperable, the bed was to be taken out of service until a qualified Hill-Rom technician can make any necessary correction. The customers were instructed to contact Hill-Rom to make arrangements and inform them of all beds that they have loaned, sold, no longer use or disposed of at 800-445-3720, option 2. The letter states the firm is evaluating a design change to the siderail.\n\nIf you have any questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720, option 2.", "product_quantity": "1,406 beds both models.", "distribution_pattern": "Worldwide distribution: USA states including: AK, FL, HI, IN, KS, LA, MS, OK, PA, TN, VT, and WA and countries including: Canada, Mexico, Angola, Australia, Saudi Arabia, Qatar, and United Emirates.", "openfda": { "k_number": [ "K821185", "K974296", "K843781", "K911893", "K903904", "K864186", "K945664", "K852674", "K902183", "K925534", "K922352", "K935837", "K951514", "K881844", "K881960", "K962250", "K831821", "K925576", "K890426", "K964515", "K875037", "K872924", "K972115", "K971546", "K982783", "K915437", "K853270", "K202964", "K931482", "K951735", "K872925", "K830559", "K932663", "K900151", "K945042", "K780371", "K854832", "K894296", "K962942", "K881782", "K811897", "K926435", "K864172", 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