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U.S. Department of Health and Human Services

Class 2 Device Recall Braun wheelchair lift, model NVL,

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  Class 2 Device Recall Braun wheelchair lift, model NVL, see related information
Date Initiated by Firm August 15, 2007
Date Posted September 22, 2010
Recall Status1 Terminated 3 on May 12, 2011
Recall Number Z-2469-2010
Recall Event ID 56686
510(K)Number K952946  
Product Classification elevator, wheelchair - Product Code ING
Product Braun wheelchair lift, model NVL, Braun Corporation, Winamac, IN
A wheelchair lift for motor vehicles.
Code Information model year 2005-2006.
Recalling Firm/
Manufacturer		 The Braun Corporation
631 W 11th St
Winamac IN 46996-1245
For Additional Information Contact Rick Nelson
219-946-6153
Manufacturer Reason
for Recall		 The wheelchair lifts threshold warning system may not operate and the wheelchair user can fall from the vehicle and be seriously injured.
FDA Determined
Cause 2		 Device Design
Action The Braun Corporation issued a Service Bulletin 34273 entitled "Lift Threshold Sensitivity Bulletin 34273 on October 2007. Braun Corporation also sent a "Safety Recall" letter to the Braun lift owner and letters to all customers on or about August 15, 2007. The letters described the product, problem and the action to be taken by the customer. The customers were instructed to notify the National Highway Traffic Safety Administration (NHTSA) and conduct a safety recall if they used recalled lifts as original equipment in a system or vehicle that they built; ensure that any associated customers are notified to discontinue the use of their vehicles until they schedule a repair, and verify the threshold warning system is within the NHTSA specification. The customers were informed to contact the NHTSA with questions by calling the Vehicle Safety Hotline at 1-888-327-4236 or go to http//www.safercar.gov. If they have any problem obtaining the needed repair or wish to schedule service with an approved Braun technician, contact the Braun Corporation Product Support at 1-800-946-7513.
Quantity in Commerce 1,518
Distribution Worldwide distribution
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 = ING and Original Applicant = CROW RIVER INDUSTRIES, INC.
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