Date Initiated by Firm |
February 07, 2003 |
Date Posted |
June 05, 2003 |
Recall Status1 |
Terminated 3 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 2 |
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 and Original Applicant = ELECTRIC MOBILITY CORP.
|