BEUDAMED
    FDA Recall Open, Classified

    F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

    Recall: Z-2656-2023 · Initiated September 8, 2023

    Recall

    Recall Number
    Z-2656-2023
    Event Number
    93054
    Firm
    GE Medical Systems China Co., Ltd. National Hi-Tech No.
    FEI Number
    3003513129
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 8, 2023
    Posted
    September 29, 2023
    Address
    19 Changjiang Road, Dev. Zone Wuxi China

    Description

    F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

    Reason

    There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.

    Action

    The consignee recall notification was sent out via FedEx on 09/08/2023. The letter instructs the consignee that they can continue to use the F2-01 Frame by completing the power down instructions located within the letter at least every 90 days, until GE HealthCare has corrected the affected device. The consignee is also requested to ensure all potential users in your facility are made aware of this safety notification and the recommended actions; retain the document for their records; and to complete and return the attached acknowledgement form to [email protected].

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Zealand, Oman, Poland, Qatar, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

    Quantity

    1638 units