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U.S. Department of Health and Human Services

Class 2 Device Recall Quickie Groove Power Wheelchair

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  Class 2 Device Recall Quickie Groove Power Wheelchair see related information
Date Initiated by Firm January 11, 2008
Date Posted August 23, 2008
Recall Status1 Terminated 3 on November 16, 2009
Recall Number Z-1532-2008
Recall Event ID 46908
510(K)Number K060531  
Product Classification Powered Wheelchair - Product Code ITI
Product Quickie Groove Power Wheelchair with QC (non-expandable) electronics, Model number EIPW13.
Code Information All wheelchairs with the QC Motor controller units with version 2.0 parameter or *.SUN file software.
Recalling Firm/
Manufacturer		 Sunrise Medical Inc
2842 N Business Park Ave
Fresno CA 93727-1328
For Additional Information Contact
559-292-2171
Manufacturer Reason
for Recall		 Product experiences a longer than expected stopping distance, which may cause injury to the user, objects, or the chair itself.
FDA Determined
Cause 2		 Software design
Action Initial phone contact began on January 11, 2008. Medical device correction letters were also sent to affected dealers.
Quantity in Commerce 141 units total
Distribution Product was distributed to 126 retailers nationwide throughout the USA, as well as Canada and Australia.
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 = ITI and Original Applicant = SUNRISE MEDICAL
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