BEUDAMED
    FDA Recall Terminated

    BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454

    Recall: Z-0450-2015 · Initiated November 4, 2014

    Recall

    Recall Number
    Z-0450-2015
    Event Number
    69783
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 4, 2014
    Posted
    December 1, 2014
    Terminated
    July 2, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454

    Reason

    Software issues

    Action

    Philips Healthcare sent an URGENT - Field Safety Notice Medical Device Correction letter dated November 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice 88200485 is intended to inform you about: " what the issues are and under what circumstances they can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct these issues. If you need any further information or support concerning these issues, please contact your local Philips representative: For North America contact the Customer Care Solutions Center (1-800-722-9377: follow the prompts). Philips apologizes for any inconveniences caused by this problem.

    Distribution

    Worldwide Distribution - USA including the states of AR, CA, FL, GA, ID, LA, ME, MI, MN, MO, MS, NJ, NY, OH, OK, PA, and TX. Government Facilities: AR, FL, MN, OH, and OK. and the countries of: Canada, China, Denmark, Germany, Italy, South Korea, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.

    Quantity

    85