Class 2 Device Recall Chauffeur

• Date Initiated by Firm: February 07, 2003
• Date Posted: June 05, 2003
• Recall Status: Terminated on March 03, 2008
• Recall Number: Z-0910-03
• Recall Event ID: 25457
• 510(K)Number: K924515
• Product Classification: Vehicle, Motorized 3-Wheeled - Product Code INI
• Product: Chauffeur Powered Scooters.
• Code Information: Chauffeur Model Numbers are C205, C215, C235, C245, C255, and C305. There are 45,679 serial numbers involved.
• Recalling Firm/ Manufacturer: Electric Mobility Corp; 599 Mantua Boulevard; One Mobility Plaza; Sewell NJ 08080
• For Additional Information Contact: Barbara Gruman; 856-468-1000 Ext. 2267
• Manufacturer Reason for Recall: The plastic tires may shatter if the tire is over-inflated and could cause serious injury.
• FDA Determined Cause: Other
• Action: All consignees were notified via personalized recall letter on 2/7/2003. The firm also posted the notice on their website on 2/14/2003. Customers will be asked to send back order form for new metal wheel tires.
• Quantity in Commerce: 45679
• Distribution: Distribution is both nationwide and international. The distribution are to retail customers, intercompany sales, and dealers. The Veterans Administration, Canada, United Kingdom.
• 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 = INI