BEUDAMED
    FDA Recall Terminated

    GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05

    Recall: Z-1421-05 · Initiated July 18, 2005

    Recall

    Recall Number
    Z-1421-05
    Event Number
    32707
    Firm
    GE Medical Systems Information Technologies
    FEI Number
    1419826
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 18, 2005
    Posted
    August 30, 2005
    Terminated
    July 22, 2006
    Address
    800 E Business Center Dr, Mount Prospect, IL, 60056-2178

    Description

    GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05

    Reason

    The potential exists for the AI1000 workstation to mix images from one study with images from another study. Mixed studies could be from the same patient or from different patients. Mixed patient images could compromise patient condition or diagnosis and treatment.

    Action

    An Urgent Medical Device Corrrection letter, DATED?, was sent to customers listing procedures to take to minimize the possibility of mixed patient images until a permanent software upgrade is installed. Installation of new software can be done by the customer or by a GE Service Representative. A Customer Reply Form accompanies the letter for customers to indicate the location, serial no., system ID, software version of their AI100 Cardiac Review Workstation; and to indicate their upgrade option, either self or GE Service.

    Distribution

    Outside the US to Austria, Australia, Canada, France, Germany, Italy, Japan, Korea, Malaysia, Norway, Spain, Switzerland, Taiwan, Thailand and United Kingdom. Within the US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and WI

    Quantity

    1,287