BEUDAMED
    FDA Recall Terminated

    Easy Access Software releases 1.1, 5.2, 6.2 & 7.2

    Recall: Z-1125-03 · Initiated June 27, 2003

    Recall

    Recall Number
    Z-1125-03
    Event Number
    26514
    Firm
    Philips Medical Systems
    FEI Number
    1000524572
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 27, 2003
    Posted
    August 12, 2003
    Terminated
    January 12, 2005
    Address
    22100 Bothell Everett Highway, Bothell, WA, 98041

    Description

    Easy Access Software releases 1.1, 5.2, 6.2 & 7.2

    Reason

    If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems.

    Action

    On 6/25/03 the firm issued a letter dated 6/15/03 to the affected customers. The letter advises of the problem and advises the customer that the firm will install corrected software in affected units.

    Distribution

    Devices were distributed to 23 hospitals and medical centers throughout the US.

    Quantity

    46 devices