Rascal UltraLite 370B manufactured by Giant Manufacturing, Taiwan.
FDA device recall Z-0417-2011 · posted 2010-11-18 · Terminated
Recall details
- Recalling firm
- Electric Mobility Corp
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- INI
- Quantity affected
- 315 units
- Distribution
- Worldwide Distribution: Throughout the US and Canada
- Date initiated
- 2010-09-27
- Date posted
- 2010-11-18
- Date terminated
- 2014-04-03
- Location
- Sewell, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS (K002616) | Electric Mobility, LLC | 2000-12-11 |