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Class 2 Device Recall Quickie Groove Power Wheelchair |
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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
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Product Classification |
Wheelchair - Product Code ITI
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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
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For Additional Information Contact |
559-292-2171
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = ITI and Original Applicant = SUNRISE MEDICAL
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