BEUDAMED
    FDA Enforcement Class II Terminated

    Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    Recall: Z-1182-2013 · Reported May 8, 2013

    Enforcement

    Recall Number
    Z-1182-2013
    Event ID
    64944
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 8, 2013
    Initiation Date
    April 4, 2013
    Classification Date
    April 26, 2013
    Termination Date
    August 12, 2013
    Address
    757 Arnold Dr Ste A, Martinez, CA, 94553-3615, United States

    Description

    Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    Reason

    Software update to fix multiple safety related issues.

    Code Info

    Syngo RT Therapist RTT 4.2.108; part number 8162815: Syngo ST Theratpist Connect RTT 4.2.108; part number 8168754

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Poland, India, Canada, Germany, United Kingdom, New Zealand, Belgium, Malaysia, Republic Korea, Ireland, Australia, Norway, Japan, Turkey, Croatia, Saudi Arabia, Colombia, P.R. China, Brazil, Thailand, Romania, Lebanon, Mexico, Italy, Sweden, Czech Republic, Russian Federation, and South Africa.

    Quantity

    245 active devices