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U.S. Department of Health and Human Services

Class 2 Device Recall Manual Wheelchairs with Transit System Option

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 Class 2 Device Recall Manual Wheelchairs with Transit System Optionsee related information
Date Initiated by FirmFebruary 02, 2009
Date PostedDecember 28, 2010
Recall Status1 Terminated 3 on January 03, 2011
Recall NumberZ-0831-2011
Recall Event ID 51260
510(K)NumberK973673 
Product Classification Mechanical wheelchair - Product Code IOR
ProductManual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.
Code Information Serial Numbers:  LXI-034554, LXI-034697, LXI-034694, LXI-034500, LXI-034609, LXI-034740, and  LXI-034741. 
Recalling Firm/
Manufacturer		 Sunrise Medical Inc
2842 N Business Park Ave
Fresno CA 93727-1328
For Additional Information Contact
559-294-2395
Manufacturer Reason
for Recall		The stabilizer bar was inadvertently omitted during the manufacturing process.
FDA Determined
Cause 2		Process change control
ActionAn Urgent: Medical Device Correction letter, dated February 2009, with certified return receipt was sent to customers in the United States; Canadian consignees were notified via e-mail. The letter identified the affected product and the reason for the recall. The letters asked customers to contact their Quickie dealer to make arrangements to have their device wheelchair corrected at no charge and to also verify their wheelchair serial number on the form. Questions should be directed towards their dealer or Sunrise Medical at 800-456-8168.
Quantity in Commerce23
DistributionWorldwide Distribution -- United States and Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IOR
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