FDAFDA · Alimentos y medicamentos·N.º oficial Z-2113-2012
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.
Publicado el 8 de agosto de 2012 · Inicio del retiro: 26 de junio de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Sunrise Medical (US) LLC
- Distribuidor
- Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.
- Lote
- Receiver Product number 109207.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States