Date Initiated by Firm |
September 27, 2010 |
Date Posted |
November 18, 2010 |
Recall Status1 |
Terminated 3 on April 03, 2014 |
Recall Number |
Z-0416-2011 |
Recall Event ID |
56978 |
510(K)Number |
K002616
|
Product Classification |
Vehicle, motorized 3-wheeled - Product Code INI
|
Product |
Rascal LiteWay 224 manufactured by Giant Manufacturing, Taiwan. |
Code Information |
No expiration date; 510 K - K002616; Device Listing #E394292; LW224, EMC Part #43062300, EMC Part #43062700 |
Recalling Firm/ Manufacturer |
Electric Mobility Corp 599 Mantua Boulevard One Mobility Plaza Sewell NJ 08080
|
For Additional Information Contact |
Donna Huesken 856-468-0270
|
Manufacturer Reason for Recall |
Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. This may result in complete failure of the seat base, causing the user to fall off the vehicle.
|
FDA Determined Cause 2 |
Device Design |
Action |
The Rascal Company (Electric Mobility Corporation) sent Urgent Medical Device Recall Notice Scooter Seat Base letters dated October 7, 2010 and November 11, 2010 letter to their affected retail customers and affected dealers. The letter instructs the reader that the seat base may become loose, causing the seat to wobble and if not replaced the wobble could lead to a complete failure of the seat base and cause an individual to fall off their vehicle and become injured. The letters also instruct the reader to replace seat bases immediately. Respone forms are attached. Seats with new seat bases will be shipped with return shipping labels to return the original base to the factory. Service representatives will replace the seat base for customers.
Customers can contact the Rascal Company about this recall at 1-800-662-4548. |
Quantity in Commerce |
166 units |
Distribution |
Worldwide Distribution: Throughout the US and Canada |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = INI and Original Applicant = ELECTRIC MOBILITY CORP.
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