BEUDAMED
    FDA Recall Open, Classified

    Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.

    Recall: Z-0721-2023 · Initiated October 28, 2022

    Recall

    Recall Number
    Z-0721-2023
    Event Number
    91159
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    October 28, 2022
    Posted
    December 16, 2022
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.

    Reason

    There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.

    Action

    GE Healthcare notified consignees on about 10/28/2022 via letter titled, "URGENT MEDICAL DEVICE CORRECTION - UPDATE." Consignees were instructed that the device can continued being used by following these instructions: 1) When a study is not present on the Study List, contact a GE Healthcare Service Representative for assistance in recovering the study. 2) In situations where study interpretation is time sensitive, interpret the study at the scanning unit or plan for an alternate means of reading studies for emergent cases. GE Healthcare will contact consignees to arrange for the correction. Consignees were also instructed to complete and return the acknowledgement form.

    Distribution

    Nationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND, NJ, NY, OK, OR, SD, TX, WI, WV, WY. International distribution to Austria, Brazil, France, Germany, Ghana, Ireland, Italy, Kuwait, Poland, Saudi Arabia, South Africa, Spain, Switzerland, United Kingdom.

    Quantity

    1 unit