BEUDAMED
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    XIO

    FDA Adverse Event
    Malfunction ·ELEKTA INC·Product code MUJ·August 26, 2016

    ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 17, 2013

    LANTIS COMMANDER 10 USER

    FDA Adverse Event
    Other ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code LNX·June 27, 2006

    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.

    FDA Recall
    Terminated ·Impac Medical Systems Inc·Product code IYE·September 9, 2011

    ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 20, 2012

    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.

    FDA Recall
    Terminated ·Impac Medical Systems Inc·Product code IYE·July 17, 2009

    MONACO

    FDA Adverse Event
    Malfunction ·IMPAC MEDICAL SYSTEMS, INC.·Product code MUJ·December 8, 2016

    MOSAIQ

    FDA Adverse Event
    Malfunction ·IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·November 29, 2016

    MOSAIQ

    FDA Adverse Event
    Injury ·IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·October 6, 2016

    MOSAIQ

    FDA Adverse Event
    Injury ·IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·December 14, 2016

    MOSAIQ

    FDA Adverse Event
    IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·September 17, 2015

    MOSAIQ

    FDA Adverse Event
    IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·July 3, 2015

    MOSAIQ

    FDA Adverse Event
    Malfunction ·IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·April 24, 2014

    MOSAIQ

    FDA Adverse Event
    Malfunction ·IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·June 12, 2014

    MOSAIQ

    FDA Adverse Event
    Malfunction ·IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·May 23, 2014

    MOSIAQ

    FDA Adverse Event
    Malfunction ·IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·June 12, 2014

    MONACO

    FDA Adverse Event
    Malfunction ·IMPAC MEDICAL SYSTEMS, INC.·Product code MUJ·December 22, 2016

    MOSAIQ

    FDA Adverse Event
    Malfunction ·IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·June 12, 2014

    XIO RTP SYSTEM

    FDA Adverse Event
    Malfunction ·IMPAC MEDICAL SYSTEMS, INC.·Product code MUJ·June 12, 2014

    MOSAIQ

    FDA Adverse Event
    Malfunction ·IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·June 12, 2014