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U.S. Department of Health and Human Services

Class 2 Device Recall Rascal Scooter/Powerchair Motorized Vehicles

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  Class 2 Device Recall Rascal Scooter/Powerchair Motorized Vehicles see related information
Date Initiated by Firm March 22, 2007
Date Posted November 21, 2007
Recall Status1 Terminated 3 on April 08, 2014
Recall Number Z-0174-2008
Recall Event ID 37879
510(K)Number K924515  
Product Classification Motorized 3-Wheeled Vehicle - Product Code INI
Product Electric Mobility Corporation (EMC)- Scooters and Turnabout Powerchairs with either an Electric Seat Lift Actuator or a Seat Post to attach the seat to the vehicle; Model Number(s) 300F, 600C, 600T, and 600F. Electronic Mobility Corporation, 599 Mantua Blvd, One Mobility Plaza, Sewell, NJ 08080
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Electric Mobility Corp
599 Mantua Boulevard
One Mobility Plaza
Sewell NJ 08080
For Additional Information Contact Barbara Gruman
856-468-0270
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
FDA Determined
Cause 2		 Process change control
Action Consumers 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 Commerce 12,625
Distribution Nationwide
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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