BEUDAMED
    FDA Recall Terminated

    CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.

    Recall: Z-0137-2017 · Initiated January 30, 2016

    Recall

    Recall Number
    Z-0137-2017
    Event Number
    75239
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 30, 2016
    Terminated
    October 5, 2020
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.

    Reason

    The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up.

    Action

    Merge Healthcare Inc. sent an Urgent Medical Device Recall letter dated January 28, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. Merge Healthcare is committed to improve efficiencies and enhancing the quality of healthcare worldwide.If you have any additional questions, call Merge Customer Service at (877) 741-5369 or [email protected].

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.

    Quantity

    844 sites potentially have the affected versions