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Vista de la lista Vista de las tarjetas
  • Dispositivo 25
  • Fabricante 5
  • Evento 124969
  • Implante 0
Device Recall MOSAIQ Oncology Information Systems
  • Modelo / Serial
    Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.
  • Descripción del producto
    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. || An image enabled electronic medical record system used for oncology workflow management. || Manufactured by: || Impac Medical Systems || 100 Mathilda Place, 5th floor || Sunnyvale, Ca 94086
  • Manufacturer
    Impac Medical Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MOSAIQ Oncology Information Systems
MOSAIQ
  • Modelo / Serial
    Versions 1.40 through 2.50, inclusive
  • Descripción del producto
    MD: Radiation Treatment Planning System Software
  • Manufacturer
    IMPAC Medical Systems
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de MOSAIQ
MOSAIQ
  • Modelo / Serial
    2.00N2 - 2.41.01D1
  • Descripción del producto
    MD: Patient health record information system application software
  • Manufacturer
    IMPAC Medical Systems
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de MOSAIQ
MOSAIQ
  • Modelo / Serial
    2.20.08, 2.00X3 SP6
  • Descripción del producto
    MD: Patient health record information system application software
  • Manufacturer
    IMPAC Medical Systems
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de MOSAIQ
SEQUENCER for Multi-Access and MOSAIQ
  • Modelo / Serial
    From version 5.00 forward, and all versions/builds of MOSAIQ released to date.
  • Descripción del producto
    MD: Radiation therapy treatment record/verify system application software
  • Manufacturer
    IMPAC Medical Systems
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de SEQUENCER for Multi-Access and MOSAIQ
Monaco RTP System
  • Modelo / Serial
    5.10.00, 5.10.01, 5.10.02, 5.11.00, 5.11.01, 5.20.00
  • Descripción del producto
    MD: Radiation therapy application software
  • Manufacturer
    IMPAC Medical Systems Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Monaco RTP System
Monaco RTP System
  • Modelo / Serial
    Version 5.10 and higher
  • Descripción del producto
    MD: Radiation therapy application software
  • Manufacturer
    IMPAC Medical Systems Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Monaco RTP System
Monaco RTP System
  • Modelo / Serial
    5.11, 5.20
  • Descripción del producto
    MD: Radiation therapy application software
  • Manufacturer
    IMPAC Medical Systems Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Monaco RTP System
Monaco RTP System
  • Modelo / Serial
    3.1 and higher
  • Descripción del producto
    MD: Radiation therapy application software
  • Manufacturer
    IMPAC Medical Systems Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Monaco RTP System
Monaco RTP System
  • Modelo / Serial
    5.10.00 and higher
  • Descripción del producto
    MD: Radiation therapy application software
  • Manufacturer
    IMPAC Medical Systems Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Monaco RTP System
XiO RTP System
  • Modelo / Serial
    Version 4.51 and higher
  • Descripción del producto
    MD: Radiation therapy treatment planning application software
  • Manufacturer
    IMPAC Medical Systems Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de XiO RTP System
Monaco
  • Modelo / Serial
    3.20 and higher
  • Descripción del producto
    MD: Radiation therapy treatment planning system
  • Manufacturer
    IMPAC Medical Systems Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Monaco
Focal
  • Modelo / Serial
  • Descripción del producto
    MD: Radiation therapy treatment planning system
  • Manufacturer
    IMPAC Medical Systems Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Focal
XiO RTP System
  • Modelo / Serial
    All | 4.1 and higher
  • Descripción del producto
    MD: Radiation therapy treatment planning system application software
  • Manufacturer
    IMPAC Medical Systems Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de XiO RTP System
XiO RTP System
  • Modelo / Serial
    all | 4.50 and higher
  • Descripción del producto
    MD: Radiation therapy treatment planning system application software
  • Manufacturer
    IMPAC Medical Systems Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de XiO RTP System
Monaco
  • Modelo / Serial
    RTP System | 3.10.00 and later
  • Descripción del producto
    MD: Radiation therapy treatment planning system
  • Manufacturer
    IMPAC Medical Systems Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Monaco
Monaco
  • Modelo / Serial
    All Monaco from 13.07.2007
  • Descripción del producto
    MD: Radiation therapy treatment planning system
  • Manufacturer
    IMPAC Medical Systems Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Monaco
MOSAIQ
  • Modelo / Serial
    N/A;N/A | All Versions
  • Descripción del producto
    MD: Patient health record information system application software
  • Manufacturer
    Impac Medical Systems, Inc
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de MOSAIQ
Sequencer
  • Modelo / Serial
    All sequencers for all M/A and MOSAIQ builds..
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: throughout the US and the countries of Australia, Austria, Belgium, Canada, China, Hong Kong, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Jordan, Morocco, Netherlands, New Zealand, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, and UK.
  • Descripción del producto
    Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA.
  • Manufacturer
    Impac Medical Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Sequencer
SEQUENCER
  • Modelo / Serial
    All sites with the configuration of the 4D IEC 1217 source file used for the Varian TrueBEam treatment machine.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (USA) - including the states of: AZ, CA, FL, NJ, NY, NV, TX, VA and WA.
  • Descripción del producto
    Impac Medical Systems Sequencer || Product Usage: The intended us of Sequencer is to assists in the process of patient treatment on a radiotherapy treatment machine. Sequencer provides the capability to notify the user of actions that need to take place prior to treatment, to display reference images for set up purposed and to auto setup the machine to predefined settings. The actual settings are read from the treatment machine, via the machines communication interface, and compared to predefined values. if a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate points during the treatment, the actual delivered values are recorded to provide treatment tracking.
  • Manufacturer
    Impac Medical Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de SEQUENCER
Device Recall Elekta Impac Software Sequencer
  • Modelo / Serial
    MOSAIQ 1.30, 1.60, 2.00, 2.10, and 2.20; including all service packs.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and country of Canada.
  • Descripción del producto
    Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ || The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. It gives the capability to notify users of actions that need to take place prior to treatment, to display reference images for set up purposes and to auto setup the machine to predefined settings.
  • Manufacturer
    Impac Medical Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Elekta Impac Software Sequencer
Device Recall Elekta Impac Software Sequencer
  • Modelo / Serial
    Sequencer for MOSAIQ 1.60W3 (including all service packs), 2.00T2 (inclusing all service packs), 2.10L5 (including all service packs) and 2.10M7 (including all service packs).
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Australia, Belgium, France, Germany, Hong Kong, Ireland, Israel, and Italy
  • Descripción del producto
    Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by Elekta Impac Software, Sunnyvale, CA. || The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine.
  • Manufacturer
    Impac Medical Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Elekta Impac Software Sequencer
Device Recall SEQUENCER for Mosaiq
  • Modelo / Serial
    Sequencer for MOSAIQ versions: 1.20, 1.30 ; 1.50 , 1.60 and 2.00, interfacing to an Elekta SL 75-5 Linacs.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, Canada, Germany, and France.
  • Descripción del producto
    SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. || Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software control.
  • Manufacturer
    Impac Medical Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SEQUENCER for Mosaiq
Device Recall MOSAIQ
  • Modelo / Serial
    MOSAIQ version 1.30 (all builds), MOSAIQ version 1.40 (all builds), MOSAIQ version 1.50 (all builds), MOSAIQ version 1.60 (all builds, and MOSAIQ version 2.0 (all builds).
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, CA, CT, FL, GA, IA, IL, KY, MI, MN, MS, ND, NJ, OH, OR, PA,TN, TX, VA, WA, WI, and WV and the country of Canada.
  • Descripción del producto
    SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2.0 (all builds). Manufactured by IMPAC Medical Systems, Inc. Sunnyvale, CA. || The intended use of SEQUENCER (a verification system) is to assist in the process of patient treatment on a radiotherapy treatment machine. SEQUENCER provides the capability to notify the users of actions that need to take place prior to treatment, to display reference images for set up purposes, and to auto setup the machine to predefined settings. Actual settings are read from the treatment machine, via the machine's communication interface, and compared to the predefined values. If a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate times during the treatment, the actual delivered values are recorded to provide treatment tracking. Treatments are initiated by the operator, via the machine control system, only after the user has verified that the treatment setup is correct. SEQUENCER does not bypass any checks put in place by the machine's control system.
  • Manufacturer
    Impac Medical Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MOSAIQ
Device Recall MOSAIQ versions 1.3 and 1.4 SEQUENCER
  • Modelo / Serial
    MOSAIQ versions 1.30 and 1.40 with Elekta iCom or Siemens DMIP
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- USA including states of OH, OK, NJ, MN, OR, TN, NY, CA, AZ, NV, IA, GA, AL, MD, MI, PA, IN, WA, FL, TX, CO, and countries to Canada, Australia, Germany, Greece and Sweden.
  • Descripción del producto
    SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO, Manufactured by IMPAC Medical Systems, Sunnyvale, CA. || Used to facilitate the delivery of defined radiotherapy treatment plans.
  • Manufacturer
    Impac Medical Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MOSAIQ versions 1.3 and 1.4 SEQUENCER

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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.