BEUDAMED
    FDA Recall Terminated

    Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02

    Recall: Z-0063-05 · Initiated October 13, 2004

    Recall

    Recall Number
    Z-0063-05
    Event Number
    30210
    Firm
    Philips Medical Systems
    FEI Number
    1218950
    Product Code
    DPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 13, 2004
    Posted
    November 2, 2004
    Terminated
    May 15, 2012
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02

    Reason

    Software can generate printed ECG's that associate incorrect patient data with the waveform

    Action

    Philips notified accounts by letter on 9/13/04 and advised users of the problem and will provide the software upgrade kit to version A.01.03.

    Distribution

    Nationwide Australia, Brazil Korea, Japan, Mexico, Singapore,Taiwan,Canada, Belgium, Germany, Lebanon, Israel, Italy, Ireland, Netherlands, Oman, Spain, Saudia Arabia,Poland, Qtar,Switzerland, UAE, UK,

    Quantity

    768 units