BEUDAMED
    FDA Recall Terminated

    BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Labeled in part ***Varian Medical Systems Inc. Oncology Systems***

    Recall: Z-0176-03 · Initiated October 31, 2003

    Recall

    Recall Number
    Z-0176-03
    Event Number
    27629
    Firm
    Varian Brachytherary Virginia
    FEI Number
    3000206172
    Product Code
    LNX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 31, 2003
    Posted
    December 3, 2003
    Terminated
    December 15, 2003
    Address
    700 Harris St, Ste 109, Charlottesville, VA, 22903-4584

    Description

    BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Labeled in part ***Varian Medical Systems Inc. Oncology Systems***

    Reason

    The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to mistreat the patient.

    Action

    The recalling firm notified consignees by Customer Technical Bulletin on 5/21/03 and additionally by 'URGENT MEDICAL DEVICE CORRECTION LETTER' on 10/31/03. The notifications caution consignees about the need to fully understand scaling functionality and to check scaling for every treatment plan. The notification further explains that the next software release will be modified to include a screen message that appears whenever automatic magnification appears.

    Distribution

    Software was distributed to end users nationwide and internationally.

    Quantity

    29 sets