Class 2 Device Recall Eleganza 5

• Date Initiated by Firm: November 13, 2019
• Create Date: January 04, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0767-2021
• Recall Event ID: 86647
• Product Classification: Bed, ac-powered adjustable hospital - Product Code FNL
• Product: 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. Its purpose is to support patient and to facilitate treatment and manipulation with patient for nursing personnel.
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• Recalling Firm/ Manufacturer: Linet Spol. S.r.o.; Zelevcice 5; Slany Czech Republic
• For Additional Information Contact: Bryan Ashe; 877-815-9897
• Manufacturer 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.
• FDA Determined Cause: 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: "Advice on action to be taken by the user: Linet 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
• Quantity in Commerce: 518 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.