Class 2 Device Recall EVA Floor Lifts

• Date Initiated by Firm: June 15, 2016
• Create Date: May 09, 2020
• Recall Status: Open, Classified
• Recall Number: Z-1943-2020
• Recall Event ID: 85362
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• Product: EVA Floor Lifts, Model Numbers: 400, 450, 600
• Code Information: All affected models
• Recalling Firm/ Manufacturer: Handicare AB; Maskinvagen 17; Lulea Sweden
• Manufacturer Reason for Recall: After feedback from customers and internal suspicion, Handicare has become aware that abnormal use of Eva-lifts could lead to a deterioation in the joint of the liftarm. This could lead to injury if the joint breaks. All lifts must therefore be checked and reported back to the manuafacturer.
• FDA Determined Cause: Device Design
• Action: The firm notified their consignees on 06/15/2016 by email. The notice explained the issue of wear in the joint of the lift arm due to abnormal use in heavy loads and/or many lifts. The consignee was directed to inspect the lifts in order to identify gaps and/or cracks and to report to the local Handicare sales representative and to Handicare. On April 4, 2019, the firm sent a reminder notice on 04/04/2019
• Quantity in Commerce: 997 units
• Distribution: US and Mexico
• 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.