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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 November 13, 2006
Date Posted September 23, 2008
Recall Status1 Terminated 3 on December 22, 2009
Recall Number Z-2339-2008
Recall Event ID 48662
510(K)Number K060531  
Product Classification Wheelchair - Product Code ITI
Product Sunrise Medical Quickie Groove Power Wheelchair with Transit option
The product is a powered wheelchair for human use.
Code Information Multiple serial numbers, starting with GRV-100: 182, 181, 178, 176, 166, 161, 160, 151, 150, 115, 110, 109, 106, 100, 099, 098, 094, 082, 081, 079, 076, 073, 064, 058, 056, 054, 053, 050, 044, 043, 041, 040, 035, 033, 021 and 013
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		 Rear bolts holding the frame in place may shear and the front bolts may potentially come off the posts, resulting in partial or full seat detachment in a sudden stop or crash.
FDA Determined
Cause 2		 Device Design
Action Initial phone contacts began on November 13, 2006. Letters were also mailed. The letter informed the customer of the problem and provided interim steps to take, until an transit upgrade kit is installed. Response cards will be tracked to measure response rate and assure receipt of notice. Contact Sunrise Medical at 1-800-456-8168 for assistance.
Quantity in Commerce 36 units
Distribution Worldwide: US, Canada, New Zealand 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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