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U.S. Department of Health and Human Services

Class 2 Device Recall ThyssenKrupp Accessibility LEVANT Stairlift.

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 Class 2 Recall
ThyssenKrupp Accessibility LEVANT Stairlift.
see related information
Date Posted December 18, 2012
Recall Status1 Terminated on January 29, 2014
Recall Number Z-0557-2013
Recall Event ID 62826
Premarket Notification
510(K) Number
K121560 
Product Classification Transport, Patient, Powered - Product Code ILK
Product ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person in a fold-down seat up and down straight stairs, indoors and outdoors.
Code Information Stairlifts sold between 12/5/08-7/31/12. The product does not have lot numbers assigned and no expiration date.
Recalling Firm/
Manufacturer
ThyssenKrupp Access Corp
4001 E 138th St
Grandview, Missouri 64030-2837
For Additional Information Contact Kevin L. Brinkman
816-965-4712
Manufacturer Reason
for Recall
The seat could break as a result of damage resulting from a seat belt being trapped underneath the foldable part of the seat when the seat belt is not buckled.
FDA Determined
Cause 2
DESIGN: Device Design
Action The firm, ThyssenKrupp Access sent an "IMPORTANT SAFETY AND PRODUCT USE INFORMATION" letter dated August 6, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-925-3100 ext. 5484 for assistance regarding this recall.
Quantity in Commerce 5,413 stairlifts
Distribution Worldwide Distribution-USA (nationwide) including the states of IL, IN, MI, OH, WI, IA, KS, MN, MO, NE, SD, AR, LA,OK, TX. AZ, CO, ID, MT, NM, UT, MT, AK, CA, HI, OR, WA, AL, FL, GA, KY, NC, SC, TN, MD, PA, VA, WV, CT, MA, ME, NH, NJ, NY, RI and VT and the countries of Canada, Nova Scotia and British Columbia
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = ILK and Original Applicant = THYSSENKRUPP ACCESSIBILITY B.V.
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