BEUDAMED
    FDA Enforcement Class II Terminated

    NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA.

    Recall: Z-2956-2020 · Reported September 23, 2020

    Enforcement

    Recall Number
    Z-2956-2020
    Event ID
    85347
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Novarad Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 23, 2020
    Initiation Date
    September 10, 2019
    Classification Date
    September 11, 2020
    Termination Date
    June 30, 2021
    Address
    752 E 1180 S Ste 200, N/A, American Fork, UT, 84003-3561, United States

    Description

    NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA.

    Reason

    The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cross-localization reference line may be inaccurately placed on any of the corresponding images that are open.

    Code Info

    NovaPACS versions 8.6.8, 8.6.9, 8.6.11, 8.6.12, 8.6.14, 8.7.4, 8.7.6, and 8.7.8

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Canada, Colombia, Dominican Republic, Indonesia, Jordan, Mexico, Peru, Phillipines, and United Kingdom.

    Quantity

    197 units