BEUDAMED
    FDA Recall Terminated

    Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications

    Recall: Z-1212-2012 · Initiated November 19, 2011

    Recall

    Recall Number
    Z-1212-2012
    Event Number
    61028
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 19, 2011
    Posted
    March 29, 2012
    Terminated
    August 26, 2020
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications

    Reason

    It was discovered there was a software error where the air karma rate is not displayed correctly on the user interface.

    Action

    A field correction action will be undertaken to correct the software error in affected systems worldwide. Your proposed action to bring the product into compliance with regulatory requirements is to institute a worldwide field correction to replace the software error in affected systems by updating the current software to version R6.1.2. The timeframe for completion of this field action will be 6 months post field action publication. Preventive actions: The software has been corrected moving forward in subsequent releases for these products. For further questions please call (978) 787-1501.

    Distribution

    Worldwide Distribution - USA (nationwide)

    Quantity

    92 ( 24 Eleva 11s, and 68 Eleva FDs )