BEUDAMED
    FDA Recall Terminated

    iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.

    Recall: Z-1470-2017 · Initiated April 4, 2016

    Recall

    Recall Number
    Z-1470-2017
    Event Number
    76654
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LMB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 4, 2016
    Posted
    March 10, 2017
    Terminated
    August 28, 2019
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.

    Reason

    The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.

    Action

    Merge Healthcare sent an Urgent: Medical Device Recall letter dated March 28, 2016, via e-mail the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016, was issued to nonresponders. The letter notifies the customer of the issue and informs them a fix has been released for the issue. 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 are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. 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. The recalling firm reported emails will be tracked for delivery confirmation and the letters will be tracked for delivery by USPS certified services. For further questions, please call (877) 741-5369.

    Distribution

    USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.

    Quantity

    187 sites potentially have the affected versions