{ "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": 1 } }, "results": [ { "cfres_id": "184252", "product_res_number": "Z-0767-2021", "event_date_initiated": "2019-11-13", "event_date_created": "2021-01-04", "recall_status": "Open, Classified", "res_event_number": "86647", "product_code": "FNL", "product_description": "Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usage: Eleganza 5 is a positionable bed for intensive care. 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S.r.o.", "address_1": "Zelevcice 5 5 zelevcice", "city": "Slany", "country": "Czech Republic", "additional_info_contact": "Bryan Ashe\n877-815-9897", "reason_for_recall": "A component used within the side rail mechanism may malfunction, resulting in the side rail either not locking properly in the upper position or the side rail becoming stuck in the upper position.", "root_cause_description": "Device Design", "action": "The firm initiated the recall by email and hand delivery on 11/13/2019. The notice explains the malfunction and risk, and provides the following information:\n\"Advice on action to be taken by the user: \nLinet has developed a correction for the side rail mechanism. We will contact you to schedule a Linet or partner technician to update your affected Eleganza 5 Beds with this correction. Until your affected beds are updated, we ask that you follow the safety information as outlined in the Eleganza 5 User manual (D9U001GE5-0101, version: 11, Publication date: 2019-11 (available at your local distributor)) when operating the side rails. Section 11.1 Side rails Chapter MANIPULATION To raise siderails up: >Grab side rail by Side Rail Handle, >Pull side rail up until it latches. You will hear audible \"click\". If you raise the side rails to the upper position and you find the side rail is not secured and/or no audible click is heard during this operation, take the bed out of service until the bed has been updated.\" Contact Linet Technical Services at phone no.: 877-815-9897", "product_quantity": "518 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K103536", "K982783", "K945664", "K971546", "K963622", "K811897", "K881844", "K831821", "K926435", "K900151", "K903904", "K951735", "K925534", "K962763", "K854832", "K872924", "K881965", "K780371", "K881782", "K931581", "K790049", "K964246", "K962942", "K972115", "K964515", "K853270", "K872925", "K881963", "K932663", "K935837", "K962250", "K854937", "K963701", "K894296", "K830559", "K890845", "K875037", "K881027", "K922352", "K946208", "K930703", "K915437", "K974296", "K821185", "K893745", "K851551", "K881960", "K873291", "K931482", "K883463", "K854867", "K911893", "K951514", "K963589", "K974254", 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