BEUDAMED
    FDA Recall Terminated

    AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.

    Recall: Z-2649-2014 · Initiated August 12, 2014

    Recall

    Recall Number
    Z-2649-2014
    Event Number
    69067
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    August 12, 2014
    Posted
    September 16, 2014
    Terminated
    May 21, 2015
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.

    Reason

    It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to fluids. Fluid may infiltrate the tableside control panel and result in malfunction. In the very unlikely case of fluid infiltration a permanent short circuit within the control panel of the Luminos dRF / Luminos dRF Max will automatically d

    Action

    Siemens sent a Customer Safety Advisory Notice XP045/14/S, dated August 12, 2014, to direct accounts, which identified the product, problem, and action to be taken to avoid potential risk to patients and users. Customers were instructed to avoid extensive exposure of fluids to the tableside control panel. When cleaning the system, customers were instructed not to appoly excessive fluids, only use damp towels, in accordance with the product manual. Customers were asked to forward the safety notice to any of their customers and to inform Siemens of the identify of the device's new owner where possible. For questions regarding this recall call 610-219-6300.

    Distribution

    Nationwide Distribution including IL VA TN PA TX IN MN NM GA MI FL CA NY ME OK MO NJ and AZ.

    Quantity

    33