BEUDAMED
    FDA Recall Terminated

    Radiation therapy system - Coherence AG Therapist Part number 5863506 and Therapist system Part number 7339125, equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1. This is a medical charged particle radiation therapy system, part of the firm's beam limiting device/accessory. The product provides data processing, and the SYNGO standard medical imaging platform to provide comprehensive oncology workflow solutions for radiation therapy.

    Recall: Z-2095-2008 · Initiated May 15, 2008

    Recall

    Recall Number
    Z-2095-2008
    Event Number
    48439
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 15, 2008
    Posted
    September 17, 2008
    Terminated
    December 20, 2010
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    Radiation therapy system - Coherence AG Therapist Part number 5863506 and Therapist system Part number 7339125, equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1. This is a medical charged particle radiation therapy system, part of the firm's beam limiting device/accessory. The product provides data processing, and the SYNGO standard medical imaging platform to provide comprehensive oncology workflow solutions for radiation therapy.

    Reason

    Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.

    Action

    An Urgent Medical Device Correction - Customer Safety Advisory Notice letter (TH014/08/S) was released on May 15, 2008. A new software patch is under construction and is planned for release in June 2008. If you have any questions contact Roland Betz at (925) 246-8407.

    Distribution

    Class II Recall - Product distribution information pending from firm.