Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0557-2013Class II

ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person...

ThyssenKrupp Access Corp / initiated 2012-08-06 / Terminated / root cause: design

ThyssenKrupp Access Corp began a recall of ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person in a fold-down seat up and down straight stairs... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0557-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ThyssenKrupp Access Corp
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.
Product code
ILK Transport, Patient, Powered
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.
Root cause tag
design
FDA root cause
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
Product codes and lots
Stairlifts sold between 12/5/08-7/31/12. The product does not have lot numbers assigned and no expiration date.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0557-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0557-2013Class IITerminatedVoluntary: Firm initiated