da Vinci SP surgical system
Publicado el 10 de junio de 2020 · Inicio del retiro: 1 de abril de 2019
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
Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Intuitive Surgical, Inc.
- Distribuidor
- U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: South Korea
- Lote
- Serial Numbers: SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, SP0030
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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