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U.S. Department of Health and Human Services

Class 2 Device Recall Quickie

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  Class 2 Device Recall Quickie see related information
Date Initiated by Firm November 15, 2005
Date Posted February 14, 2006
Recall Status1 Terminated 3 on December 28, 2006
Recall Number Z-0518-06
Recall Event ID 34155
510(K)Number K031289  
Product Classification Wheelchair, Powered - Product Code ITI
Product Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair;

Product is manufactured and distributed by

Sunrise Medical, 2842 Business Park Ave., Fresno, CA 93727
Code Information Serial numbers: 1GMo1B5500522 1GL02B7500022, 1GL02B7500019, 1GM01B6500422, 1GL02B9400338  
Recalling Firm/
Manufacturer		 Sunrise Medical Inc
2842 N Business Park Ave
Fresno CA 93727-1328
Manufacturer Reason
for Recall		 While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position.
FDA Determined
Cause 2		 Other
Action On November 9, 2005, the firm contacted its consignees via telephone, which was followed up by a mailing, to alert them of the situation. The firm is making arrangements to conduct the service correction at users'' residence. All appointmens are scheduled to be completed by December 15, 2005.
Quantity in Commerce 5 units
Distribution All 5 units were distributed to direct consignees, in CA, MA, NC, and OH.
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, INC.
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