BEUDAMED
    FDA Recall Terminated

    Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Used in Radiology.

    Recall: Z-2469-2015 · Initiated August 11, 2015

    Recall

    Recall Number
    Z-2469-2015
    Event Number
    71964
    Firm
    GE Healthcare
    FEI Number
    3004526608
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    August 11, 2015
    Posted
    August 27, 2015
    Terminated
    January 5, 2017
    Address
    540 W Northwest Hwy, Barrington, IL, 60010-3051

    Description

    Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Used in Radiology.

    Reason

    Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.

    Action

    The firm sent out an Urgent Medical Device Correction letter dated 8/11/2015 to all affected customers. Letter states that No User activity required. GE Healthcare has completed a remote inspection of your system and found that this system parameter is currently set to the default setting of 1. The firm will correct all affected systems by a providing software update. The letter also states that if the customer has any questions they should call GE Healthcare Service at 1-800-437-1171 or their local service representative.

    Distribution

    Worldwide Distribution - U.S. nationwide in the states of: AK, CA, CO, DE, FL, HI, ID, NY, PA, SD, TN and TX; France, Germany, Greece, India, Israel, Malaysia, Mexico, Northern Ireland (UK), Panama, Poland, Russia, South Africa, Saudi Arabia, Switzerland, Turkey, UAE and Uruguay.

    Quantity

    82 systems