Class 2 Device Recall

• Date Initiated by Firm: May 05, 2005
• Date Posted: August 17, 2005
• Recall Status: Terminated on October 03, 2006
• Recall Number: Z-1376-05
• Recall Event ID: 32657
• 510(K)Number: K924515
• Product Classification: Wheelchair, Powered - Product Code ITI
• Product: UltraLite Vehicles powered by Rascal Motorized Vehicles.
• Code Information: All units distributed under Model Number UL370.
• Recalling Firm/ Manufacturer: Electric Mobility Corp; 599 Mantua Boulevard; One Mobility Plaza; Sewell NJ 08080
• For Additional Information Contact: Barbara L. Gruman; 856-468-1000
• Manufacturer Reason for Recall: The engager set screw may become loose. This problem may cause the potentiometer to become off-center thus affecting the end users stopping capabilities.
• FDA Determined Cause: Other
• Action: The firm sent out letters to their customers on 4/20/2005. The firm's sales representatives were also notified on 4/20/2005.
• Quantity in Commerce: 788 units
• Distribution: The firm sells the vehicles via direct sales to end customers and also to company owned inventory with sales representatives. The distribution is nationwide.
• 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.

• 510(K) Database: 510(K)s with Product Code = ITI