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U.S. Department of Health and Human Services

Class 2 Device Recall Quickie Q7 Adult Rigid Wheelchair

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  Class 2 Device Recall Quickie Q7 Adult Rigid Wheelchair see related information
Date Initiated by Firm December 19, 2014
Date Posted January 27, 2015
Recall Status1 Terminated 3 on March 10, 2015
Recall Number Z-1020-2015
Recall Event ID 70141
510(K)Number K123975  
Product Classification Wheelchair, mechanical - Product Code IOR
Product Quickie Q7 Adult Rigid Wheelchair Model EIR4.
Code Information Serial numbers: R4-025066, R4-025051, R4-025010, R4-024771, R4-024738, R4-024649.
Recalling Firm/
Manufacturer		 Sunrise Medical (US) LLC
2842 Business Park Ave
Fresno CA 93727-1328
For Additional Information Contact Laurie H. Roberts MS, RAC
559-348-2572
Manufacturer Reason
for Recall		 There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
FDA Determined
Cause 2		 Device Design
Action Sunrise Medical sent an Urgent Medical Device Field Correction letters dated December 19, 2014 to the two affected distributors. The letter identified the affected product, problem and actions to be taken. For question contact Sunrise Medical Regulatory Affairs at either (559)294-2840.
Quantity in Commerce 6
Distribution Nationwide Distribution in the states of CO and ME.
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 = IOR and Original Applicant = SUNRISE MEDICAL
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