FDA-Device2014-09-24Class II

TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.

Motion Concepts
Hazard

Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position System (TRx Vertical Positioner).

Sold states
US Distribution in states of: AR, CA, CT, DE, IA, ID, IL, IN, MI, MD, MO, NE, NY, OH, PA, TN, TX, and WA.
Affected count
US: 59 units
Manufactured in
84 Citation Drive, Units 1-7, Concord, N/A, Canada
Products
TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2657-2014

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