FDAFDA · Alimentos y medicamentos·N.º oficial Z-1986-2015
Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.
Publicado el 15 de julio de 2015 · Inicio del retiro: 9 de abril de 2015
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
On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use scenarios when the bar is rotated and twisted around the snap hook. The snap hook could open, resulting in possible injury to the user due to a fall.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- BTE Technologies, Inc.
- Distribuidor
- Worldwide Distribution - Nationwide Distribution and to the countries of : Austria, Belgium, Canada, France, Germany, Greece, Hong Kong, Italy, India, Japan, South Korea, Mexico, P.R. China, Poland, Republic of South Africa, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand, and United Kingdom.
- Lote
- Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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