BEUDAMED
    FDA Recall Terminated

    ClearCanvas RIS/PACS

    Recall: Z-1758-2020 · Initiated February 26, 2020

    Recall

    Recall Number
    Z-1758-2020
    Event Number
    85216
    Firm
    Synaptive Medical Inc
    FEI Number
    3012075008
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 26, 2020
    Terminated
    April 10, 2024
    Address
    555 Richmond St West, Toronto Canada Suite 800

    Description

    ClearCanvas RIS/PACS

    Reason

    A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.

    Action

    The firm initiated this field corrective action by letter on 02/26/2020. The consignees are not required to discontinue using the device nor return the device to Synaptive Medical, a workaround is to be followed as indicated in the customer notification letter. The actions to be taken by consignees with the affected product are as follows: 1. Acknowledge receipt of the notification using the acknowledgment and receipt form that the firm has provided. 2. a) If ClearCanvas Workstation is NOT used for viewing images on removeable media such as CDs, and this issue is encountered, configure the PACS or DICOM device that is sending images to ClearCanvas Workstation to send uncompressed images, or images compressed with a compression algorithm other than JPEG 2000. b.) If ClearCanvas Workstation IS used for viewing images on removeable media such as CDs OR if it is not possible to change the sending device to send uncompressed images, contact Synaptives Product Support Recall Line at 1.866.853.8001 to request assistance to correct the device. Note that if the software is subsequently re-installed, the device will need to be corrected again. Contact Synaptive to repeat the correction.

    Distribution

    US

    Quantity

    903 units