Z-0417-2011
Rascal UltraLite 370B manufactured by Giant Manufacturing, Taiwan
Electric Mobility / initiated 2010-09-27 / Terminated / root cause: design
Electric Mobility Corp began a recall of Rascal UltraLite 370B 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-0417-2011
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Electric Mobility
- Product
- Rascal UltraLite 370B 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
- 315 units
- Distribution
- Worldwide Distribution: Throughout the US and Canada
- Product codes and lots
- No expiration date; 510 K - K002616; Device Listing #E394292; UL370B, EMC Part #42021011, EMC Part #42021012
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
