BEUDAMED
    FDA Recall Terminated

    GE Centricity PACS (Picture Archiving and Communication System) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment.

    Recall: Z-1549-2009 · Initiated April 3, 2009

    Recall

    Recall Number
    Z-1549-2009
    Event Number
    51501
    Firm
    GE Healthcare Integrated IT Solutions
    FEI Number
    3004526608
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 3, 2009
    Posted
    July 1, 2009
    Terminated
    May 25, 2012
    Address
    540 W Northwest Hwy, Barrington, IL, 60010-3051

    Description

    GE Centricity PACS (Picture Archiving and Communication System) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment.

    Reason

    There is a potential safety issue associated with the use of GE Centricity PACS software related to configuration of DICOM query retrieval with rejected images.

    Action

    GE Healthcare Integrated IT Solutions sent an "Urgent Medical Device Correction" letter dated April 2, 2009 to their Centricity PACS software versions 2.1.x and 3.0.x customers with attention to the Director of Radiology, the Hospital Administrator, the Head of the Radiology Department and the PACS Administrator. The letters advised users of the patient safety issue associated with the affected device and provided safety instructions to follow until the software is updated. User were asked to complete the enclosed Customer Reply form and fax the completed form to 1-847-939-1479. Centricity PACS Software Versions 1.0.x and 2.0.x customers were sent separate letters explaining the issue and the safety instructions to follow, but there will be no software updates since those software versions are no longer being supported. Any questions should be directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 1-800-437-1171.

    Distribution

    Worldwide Distribution - United States including Puerto Rico and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.

    Quantity

    1,188 units