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U.S. Department of Health and Human Services

Class 2 Device Recall Rascal Liteway Scooter Model 214

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  Class 2 Device Recall Rascal Liteway Scooter Model 214 see related information
Date Initiated by Firm September 27, 2010
Date Posted November 18, 2010
Recall Status1 Terminated 3 on April 03, 2014
Recall Number Z-0415-2011
Recall Event ID 56978
510(K)Number K002616  
Product Classification Vehicle, motorized 3-wheeled - Product Code INI
Product Rascal LiteWay 214 manufactured by Giant Manufacturing, Taiwan.
Code Information No expiration date; 510 K - K002616; Device Listing #E394292; LW214, EMC Part #43062400, EMC Part #43062500 LW3 Plus, EMC Part #43062600 LW3x6, EMC Part #43062800
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 172 units
Distribution Worldwide Distribution: Throughout the US and Canada
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.
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