BEUDAMED
    FDA Recall Terminated

    MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.

    Recall: Z-0985-2012 · Initiated January 9, 2012

    Recall

    Recall Number
    Z-0985-2012
    Event Number
    60898
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 9, 2012
    Posted
    February 8, 2012
    Terminated
    February 13, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.

    Reason

    Incorrect Skin Dose calculation. AKR (Air Kerma Rate) displayed and stored in patient records is too low

    Action

    Philips Healthcare issued a mandatory Urgent Field Safety Noticedated October 3, 2011 to all affected customers. The letter identifies the affected product, problem description, hazard involved, action to be taken by customer/user and actions planned by Philips to correct the problem. The letter provide important information for the continued safe and proper use of the equipment. The letter instructs customers to review the following information with all members of their staff who need to be aware of the contents of this communication and retain a copy with the equipment Instruction for Use. For further information or support concerning this issue contact your local Philips representative at 866-767-2822.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of CA, IL, OH, SD, TX, WY and the countries of: Australia, Austria, Canada, Egypt, Germany, mexico, Turkey and UK

    Quantity

    10 units (US)