BEUDAMED
    FDA Recall Terminated

    Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A

    Recall: Z-1128-2007 · Initiated June 11, 2007

    Recall

    Recall Number
    Z-1128-2007
    Event Number
    38239
    Firm
    Philips Medical Systems
    FEI Number
    1218950
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 11, 2007
    Posted
    August 7, 2007
    Terminated
    August 8, 2016
    Address
    3000 Minuteman Road, Andover, MA, 01810-1032

    Description

    Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A

    Reason

    The ECG signal may become unusable to assess patient condition and need for therapy.

    Action

    Philips Medical contacted accounts by letter dated June 11, 2007. Users are advised to remove product from service, if possible. If not, a back up unit should be available to use. Service reps will contact accounts to replace units.

    Distribution

    Worldwide, including USA, Canada, Australia, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Kuwait, Macau, Poland, Portugal, Romania, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, UK, and Venezuela.

    Quantity

    312 units