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U.S. Department of Health and Human Services

Class 2 Device Recall Rascal Scooter

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 Class 2 Device Recall Rascal Scootersee related information
Date Initiated by FirmMarch 29, 2007
Date PostedNovember 21, 2007
Recall Status1 Terminated 3 on April 08, 2014
Recall NumberZ-0175-2008
Recall Event ID 37880
510(K)NumberK924515 
Product Classification Powerchair Motorized Vehicles - Product Code INI
ProductRascal Scooters with Electric seat lifts, Model 600 Series, distributed between 10/27/2005 - 3/31/2006, Electric Mobility Corporation (EMC), Sewell, New Jersey 08080
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Electric Mobility Corp
599 Mantua Boulevard
One Mobility Plaza
Sewell NJ 08080
For Additional Information ContactBarbara Gruman
856-468-1000 Ext. 2267
Manufacturer Reason
for Recall		Seat and/or lift actuator problems: 1) Models equipped with a Seat Lift, the mast screw and washer holding the Seat Lift Actuator in place will loosen break off or fall out; 2) Models assembled with Seat Lift Actuator or Seat Post Mounting Bolts, the seat may wobble or the seat will break off from the vehicle; 3) Models using Seat-On Lifting brackets with a hoist to raise an EMC vehicle equipped w
FDA Determined
Cause 2		Process change control
ActionConsumers were sent an Urgent Medical Device Recall Notification on October 12, 2007, requesting that they immediately respond to the Medical Device Recall by calling EMC at 1-800-814-4365, or by returning an enclosed Recall Response Form, or by responding on-line at www.EMCIT.NET/801B. The Notification address three important safety issues on 1) Seat Lift Actuator Mast Screws and Washers; 2) Seat Lift Actuator or Seat Post Mounting Bolts and; 3) Incorrect Seat-On Lift Bracket Installation. Corrections to the devices will be made by the nearest Service Representatives, by scheduled in-home repairs, or return of the rear section of the scooter with EMC providing shipping material and freight payment.
Quantity in Commerce1,756
DistributionNationwide: to consumers via direct purchase from Electric Mobility Corporation.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = INI
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