Z-2113-2012 Class II Terminated

Recalled by Sunrise Medical (US) LLC — Fresno, CA

Recall Details

Product Type
Devices
Report Date
August 8, 2012
Initiation Date
June 26, 2012
Termination Date
November 1, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14, 035

Product Description

Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.

Reason for Recall

Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm.

Distribution Pattern

Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.

Code Information

Receiver Product number 109207.