BEUDAMED
    FDA Recall Completed

    MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008

    Recall: Z-0919-2022 · Initiated March 16, 2022

    Recall

    Recall Number
    Z-0919-2022
    Event Number
    89834
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    DQK
    Status
    Completed
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    March 16, 2022
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008

    Reason

    Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.

    Action

    GE Healthcare notified its consignees by letter titled URGENT MEDICAL DEVICE CORRECTION on March 16, 2022. The letter explained the two scenarios which would produce the loss of edits and provided recommendations and a workaround. The firm will correct all affected products at no cost to you. The firm will be issuing a software patch. A GE Healthcare representative will contact affected customers to arrange for the correction. If you have any questions or concerns regarding this notification, contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative

    Distribution

    US and Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, England, France, Germany, Ireland, Italy, Korea, Malaysia, Netherlands, Norway, Poland, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Taiwan, Turkey

    Quantity

    147 units