BEUDAMED
    FDA Recall Terminated

    Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

    Recall: Z-0508-2015 · Initiated April 8, 2014

    Recall

    Recall Number
    Z-0508-2015
    Event Number
    67869
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 8, 2014
    Posted
    December 16, 2014
    Terminated
    May 31, 2018
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

    Reason

    In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.

    Action

    Philips Healthcare sent an Important Electronic Product Radiation Warning letters dated April 8, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter alerts customers of the product defect and advises customers of Philips' plan to update the ATP software. A Philips Service Engineer will contact the customer when the Field Action Kit is released for installation. A customer notification letter which includes a statement that Philips Healthcare will without charge, remedy the defect or bring the product into compliance. Customers with questions about this issue can contact their local Philips representative or Philips Healthcare office, or call the Customer Care Solutions Center at 800-722-9377, Option 5. Callers should reference Field Correction Order FCO-71200109.

    Distribution

    Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI.,and the countries of : Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Iraq, Ireland, Italy, Jordan, Liberia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Arab Emirates and United Kingdom.

    Quantity

    247 in US, 1 in Puerto Rico