Z-2113-2012 Class II Terminated
FDA device recall Z-2113-2012 was initiated by Sunrise Medical (US) LLC on June 26, 2012 and is designated Class II. 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. The recall status is terminated (terminated November 1, 2012). Affected quantity: 14, 035.
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.