FDAFDA · Alimentos y medicamentos·N.º oficial Z-2247-2012
Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.
Publicado el 29 de agosto de 2012 · Inicio del retiro: 27 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
Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (M¿V) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Stryker Medical Division of Stryker Corporation
- Distribuidor
- Worldwide Distribution -- USA (nationwide) including the states of AK, AL, AZ, CA, FL, ID, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OR, PA, TN, TX, UT, UT, VA, WA, WI, and WV, and the country of Canada.
- Lote
- Model: EMS24 with serial codes: 100346, 100348, 100355, 100356, 100357, 100358, 100359, 100360, 100362, 100363, and 100364.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States