BEUDAMED
    FDA Recall Terminated

    COHERENCE Oncologist, Model Nos. 07333680 & 07351898

    Recall: Z-1346-2020 · Initiated January 16, 2020

    Recall

    Recall Number
    Z-1346-2020
    Event Number
    84795
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    January 16, 2020
    Terminated
    January 4, 2021
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    COHERENCE Oncologist, Model Nos. 07333680 & 07351898

    Reason

    A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead to incorrect repositioning of the patient and dose to wrong location.

    Action

    The firm started notifying customers on January 16, 2020, with letters titled Urgent Medical Device Correction. Customers were advised of the product safety issue. To avoid the possibility of an incorrect alignment of the patient, the user must ensure that filtered images arrive on the COHERENCE Oncologist, or apply any additional filters to the image BEFORE using the "interactive shift" or "landmark registration" tools. The firm will be offering a software solution for the issue free of charge. The firm's letter stated that based on their investigation, customers may continue to use their devices.

    Distribution

    Domestic distribution to CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV. Worldwide foreign distribution.

    Quantity

    64 Worldwide/26 Domestic