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U.S. Department of Health and Human Services

Class 2 Device Recall Rascal 600

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 Class 2 Device Recall Rascal 600see related information
Date Initiated by FirmApril 17, 2006
Date PostedMay 24, 2006
Recall Status1 Terminated 3 on April 08, 2014
Recall NumberZ-0903-06
Recall Event ID 35181
510(K)NumberK002616 K924515 K972370 
Product Classification Wheelchair, Powered - Product Code ITI
ProductRascal 600F and 600T scooters, unspecified power wheelchair.
Code Information Numerous serial numbers
Recalling Firm/
Manufacturer		 Electric Mobility Corp
599 Mantua Boulevard
One Mobility Plaza
Sewell NJ 08080
Manufacturer Reason
for Recall		The four seat mast mounting screws can loosen, causing seat to wobble. The chair seat actuator and portions of the seat can malfunction and/or break. Firm is aware of problems with the seat and injuries sustained from the powered wheelchair/scooter seat malfunction. Firm has not initiated recall, claims it is a Warranty Advisory.
FDA Determined
Cause 2		Other
ActionAt this point, the firm has committed to send out a Warranty advisory. No recall has been initiated.
Quantity in Commerce12,220 chairs
DistributionTo customers nationwide.
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 = ITI
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