BEUDAMED
    FDA Recall Terminated

    Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.

    Recall: Z-2551-2016 · Initiated July 23, 2015

    Recall

    Recall Number
    Z-2551-2016
    Event Number
    74846
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 23, 2015
    Terminated
    October 7, 2016
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.

    Reason

    The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.

    Action

    The firm, Merge, sent a "canned" email on 7/23/2015 to its customers which also contained a personal message. The recalling firm issued a second letter entitled "URGENT: MEDICAL DEVICE RECALL" dated 1/27/2016 via e-mail on 1/30/2016. The letters described the product, problem and actions to be taken. The letter informed customers that an upgrade is available. The customers were instructed to call Merge Customer Service at (877) 741-5369 or send an email to [email protected] to schedule the upgrade-Reference this recall #2016-14. If you decide to decline this maintenance release, complete the attached form and return to Merge Healthcare via [email protected]. Alternatively, complete the online form: http://www.merge.com/Landing-Pages/Customer-Upgrade-Decline-Form.aspx no later than February 22, 2016. Ensure that all users of the product are provided with this notification. If you have further distributed this, identify your customers and notify them at once of this product recall and provide a copy of the recall notification letter. If you have any additional questions, call Merge Customer Service at (877) 741-5369 or [email protected].

    Distribution

    US Distribution to states of: CA, PA, TX, and MT.

    Quantity

    9 sites potentially have the affected version