BEUDAMED
    FDA Recall Terminated

    EasyDiagnost. Multi-functional R/F systems used for general R/F, Fluoroscopy, Radiography and Angiography examinations.

    Recall: Z-0849-2010 · Initiated January 21, 2010

    Recall

    Recall Number
    Z-0849-2010
    Event Number
    54641
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    IXR
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    January 21, 2010
    Posted
    March 23, 2010
    Terminated
    January 25, 2011
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    EasyDiagnost. Multi-functional R/F systems used for general R/F, Fluoroscopy, Radiography and Angiography examinations.

    Reason

    Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.

    Action

    Urgent - Field Safety Notice letters, dated January 20 & 21, 2010, were sent to customers. The letter identified the affected products, gave a description of the problem & the hazard involved, stated how to identify affected products, actions to be taken by the customer or user, and actions planned by the firm. Customers are to make sure that the relevant safety precautions are observed and check their operators console (EEC) if the labeling is present as shown in the drawing. If the labeling is missing, a Philips rep should be contacted. For further information or support concerning the issue, a Philips rep should be contacted at 800-722-9377.

    Distribution

    Devices were distributed through out the US in the following states: AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, WI, and WY.

    Quantity

    11 units