BEUDAMED
    FDA Recall Terminated

    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.

    Recall: Z-2709-2016 · Initiated February 9, 2016

    Recall

    Recall Number
    Z-2709-2016
    Event Number
    75027
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 9, 2016
    Posted
    September 1, 2016
    Terminated
    August 24, 2017
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.

    Reason

    A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).

    Action

    MERGE sent an Urgent Medical Device Recall letter dated February 9, 2016, to all affected customers via email or via certified mail if they did not have an e-mail address for 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. For further questions, please call (800) 724-5970 ext. 8027.

    Distribution

    Nationwide Distribution

    Quantity

    116 customers potentially have the affected versions