BEUDAMED
    FDA Recall Terminated

    Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt.

    Recall: Z-1126-03 · Initiated March 5, 2003

    Recall

    Recall Number
    Z-1126-03
    Event Number
    26637
    Firm
    Olympus America Inc. Two
    FEI Number
    2429304
    Product Code
    LMB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 5, 2003
    Posted
    August 12, 2003
    Terminated
    March 22, 2005
    Address
    Corporate Center Drive, Melville, NY, 11747

    Description

    Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt.

    Reason

    Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.

    Action

    Olympus America, Inc. sent "Urgent-Device Correction" letters, dated 3/5/03, to the medical facilities, advising them of the software malfunction. The letter provides instructions to health care practitioners and that a new software release is being developed to prevent a recurrence.

    Distribution

    Medical facilities nationwide and Puerto Rico; and 4 foreign accounts in Canada, Ecuador, Chile & Mexico.

    Quantity

    856