BEUDAMED
    FDA Recall Open, Classified

    GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"

    Recall: Z-0519-2022 · Initiated November 4, 2021

    Recall

    Recall Number
    Z-0519-2022
    Event Number
    89102
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IYO
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    November 4, 2021
    Posted
    January 24, 2022
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"

    Reason

    The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

    Action

    The firm distributed an Urgent Medical Device Correction letter to customers on 11/17/2021 informing customers of the issue with Vscan Extend devices not powering on because of depleted internal battery. This issue occurs if the device is not turned off prior to the external battery being removed or when the device is connected to a personal computer without connecting to AC power. The actions needed to be taken by the user until a software update could be deployed were identified in this notice as: make sure to power off the Vscan Extend device before removing the external battery, always connect the device to AC power when it is connected to a PC, and if the device is being used outside of a normal hospital or clinic setting where it is the only imaging device available, ensure the device functionality is checked daily or before each shift. Attached to the notification was an Acknowledgment Response form that was to be returned by email within 30 days of receipt of the notice. Customers with any questions are to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.

    Distribution

    Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, PR, and DC. International: Albania, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dubai, Ecuador, El Salvador, Estonia, Fiji, Finland, France, Germany, Greece, Haiti, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Malta, Mexico, Moldova, Morocco, Myanmar, Netherlands, New Zealand, Norway, Papua New Guinea, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Somalia, South Africa, Spain, Sweden, Switzerland, Thailand, Togo, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam, and Western Sahara.

    Quantity

    12,526 total reported units (9,771 units of this model)