FDAFDA · Alimentos y medicamentos·N.º oficial Z-2853-2026
Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum Rival Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Publicado el 12 de agosto de 2026 · Inicio del retiro: 25 de junio de 2026
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Pride Mobility Products Corp.
- Distribuidor
- Worldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.
- Lote
- Lot Code: Quantum Rival 0060650920013*4 K011993 D049085 41875 ITI
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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