BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.

    Recall: Z-2292-2014 · Reported September 17, 2014

    Enforcement

    Recall Number
    Z-2292-2014
    Event ID
    68785
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 17, 2014
    Initiation Date
    July 7, 2014
    Classification Date
    September 10, 2014
    Termination Date
    February 24, 2015
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.

    Reason

    It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. This may also result in an overexposed image that is not of diagnostic quality. As a result the taken examination needs to be repeated. Thi

    Code Info

    model numbers 10094200, 10281163, 10281013, 10094910 with multiple serial numbers

    Distribution

    Nationwide Distribution.

    Quantity

    192