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.
- Company
- Sunrise Medical (Us) Llc
- Recall Initiated
- June 26, 2012
- Posted
- July 31, 2012
- Terminated
- November 1, 2012
- Recall Number
- Z-2113-2012
- Quantity
- 14, 035
- Firm Location
- Fresno, CA
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
Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.
Lot / Code Info
Receiver Product number 109207.
Root Cause
Labeling design
Action Taken
Sunrise Medical sent a Safety Notice letter dated June 25, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter request that clinicians/suppliers post this safety notice in a conspicuous location, making customers and therapists aware of the issue. The letter also encourage end users to read the owner's manual and follow the recommenations for proper usage of the recalled product. Customers are instructed to complete and return the Supplier Notification and Response Form. For questions contact Sunrise Medical Regulatory Affairs at 888-208-4901.