BEUDAMED
    FDA Recall Terminated

    Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

    Recall: Z-1415-2017 · Initiated April 4, 2016

    Recall

    Recall Number
    Z-1415-2017
    Event Number
    76401
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 4, 2016
    Posted
    March 8, 2017
    Terminated
    March 20, 2017
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

    Reason

    A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.

    Action

    Merge sent an Urgent: Medical Device Recall letter dated March 28, 2016, via e-mail on April 4, 2016. A letter was issued to nonresponders on July 11, 2016. The letter notifies the customer of the issue, informs them of the workaround, and that no further action was being taken to correct the issue, therefore, the customer needs to be aware of the possible behavior. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they understand the workaround. The response was required no later than April 18, 2016. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 2, 2016. The letter and response form contained the same information as the first letter. If the second letter results in additional unresponsive customers, a call campaign will be managed by Customer Support and documented via SalesForce. Three call attempts will made before closing the case. For further information please call (877) 741-5369.

    Distribution

    US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.

    Quantity

    17 sites potentially have the affected versions