Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0415-2011

Rascal LiteWay 214 manufactured by Giant Manufacturing, Taiwan

Electric Mobility / initiated 2010-09-27 / Terminated / root cause: design

Electric Mobility Corp began a recall of Rascal LiteWay 214 manufactured by Giant Manufacturing, Taiwan on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0415-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Electric Mobility
Product
Rascal LiteWay 214 manufactured by Giant Manufacturing, Taiwan.
Product code
INI Vehicle, Motorized 3-Wheeled
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.
Root cause tag
design
FDA root cause
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
Product codes and lots
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