Class 2 Device Recall Pilot

• Date Initiated by Firm: March 02, 2020
• Create Date: April 01, 2020
• Recall Status: Terminated on September 18, 2023
• Recall Number: Z-1632-2020
• Recall Event ID: 85154
• Product Classification: Accessories, wheelchair - Product Code KNO
• Product: Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
• Code Information: Model: E60424YLMUB; SN: MU180600588; (01) 04714379292589 (11)190604 (21) MU190600025.
• Recalling Firm/ Manufacturer: Merits Holdings Co. dba Merits Health Products, Inc.; 4245 Evans Ave; Fort Myers FL 33901-9311
• For Additional Information Contact: Dwight Crostreet; 239-772-0579
• Manufacturer Reason for Recall: Pinion gear may disengage from track allowing lift to slip or jolt.
• FDA Determined Cause: Device Design
• Action: Merits Health Products notified customers on 03/17/2020 via "Medical Device Field Correction E604 Pilot Navigator" letter. The letter identified the affected product and requested the customers to complete the form.
• Quantity in Commerce: 82 units.
• Distribution: US Nationwide distribution in the states of AZ, CA, CT, FL, GA, IN, MA, MD, ME, MO, NC, OH, PA, TX, and VA.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.