BEUDAMED
    FDA Recall Terminated

    (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system

    Recall: Z-0374-2014 · Initiated September 3, 2013

    Recall

    Recall Number
    Z-0374-2014
    Event Number
    66231
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 3, 2013
    Posted
    November 26, 2013
    Terminated
    February 24, 2015
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system

    Reason

    A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality.

    Action

    Siemens Healthcare sent a Field Safety Notice dated September 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Field Safety Notice to any new users and provide the new owner information to Siemens Healthcare. Customers were asked to send back the attached form confirming receipt of the Field Safety Notice. Customers with questions should call 610-850-4634. For questions regarding this recall call 610-219-6300.

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Canada.

    Quantity

    357