BEUDAMED
    FDA Enforcement Class II Ongoing

    GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"

    Recall: Z-0524-2022 · Reported February 2, 2022

    Enforcement

    Recall Number
    Z-0524-2022
    Event ID
    89102
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 2, 2022
    Initiation Date
    November 4, 2021
    Classification Date
    January 24, 2022
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"

    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.

    Code Info

    Information reads "Serial Number (UDI, Model Number)". VH200223DX (01008406821216511120100821VH200223DX, H41212ZD), VH150287BJ (01008406821216511118010021VH150287BJ, H41212RS), VH200066HU (01008406821216511119120021VH200066HU, H41212ZD), VH200162ER (01008406821216511120071621VH200162ER, H41212ZC), VH20016794 (01008406821216511120071521VH20016794, H41212ZC), VH150601D6 (01008406821216511119011821VH150601D6, H41212ZC), VH200230XX (01008406821216511120071621VH200230XX, H41212ZC), VH200169VK (01008406821216511120071521VH200169VK, H41212ZC), VH200237TC (01008406821216511120071621VH200237TC, H41212ZC), VH200132U6 (01008406821216511120010021VH200132U6, H41212ZC), VH150275W5 (01008406821216511117090021VH150275W5, H41212RS), VH1504669B (01008406821216511118110021VH1504669B, H41212ZC), VH1508481L (01008406821216511119090021VH1508481L, H41212ZC), VH150284N3 (01008406821216511117100021VH150284N3, H41212RS), VH150265SH (01008406821216511117070021VH150265SH, H41212RS), VH1502694X (01008406821216511117070021VH1502694X, H41212RS), VH150433TG (01008406821216511118110021VH150433TG, H41212ZC), VH150968IT (01008406821216511119070021VH150968IT, H41212ZC), VH200286ZF (01008406821216511120082121VH200286ZF, H41212ZC), VH15036053 (01008406821216511118030021VH15036053, H41212RS), VH1503587A (01008406821216511118030021VH1503587A, H41212RS), VH150958Z4 (01008406821216511119060021VH150958Z4, H41212ZC), VH1502743H (01008406821216511117080021VH1502743H, H41212RS), VH150221EE (01008406821216511117090621VH150221EE, H41212RS), VH150909SW (01008406821216511119060021VH150909SW, H41212ZC), VH1509252J (01008406821216511119060021VH1509252J, H41212ZC), VH150620EN (01008406821216511119060021VH150620EN, H41212ZC), VH150902EF (01008406821216511119060021VH150902EF, H41212ZC), VH1509347X (01008406821216511119060021VH1509347X, H41212ZC), VH15083871 (01008406821216511119050021VH15083871, H41212ZC), VH150839JY (01008406821216511119050021VH150839JY, H41212ZC), VH15075671 (01008406821216511119032121VH15075671, H41212ZC), VH150736AR (01008406821216511119032021VH150736AR, H41212ZC), VH150657SF (01008406821216511119030721VH150657SF, H41212ZC), VH150388NZ (01008406821216511118050021VH150388NZ, H41212ZC), VH150617DA (01008406821216511118120021VH150617DA, H41212ZC), VH1503194P (01008406821216511118040021VH1503194P, H41212ZC), VH200346QM (01008406821216511120100821VH200346QM, H41212ZC), VH2003445A (01008406821216511120100821VH2003445A, H41212ZC), VH150610SB (01008406821216511119010021VH150610SB, H41212ZC), VH150289ZR (01008406821216511118010021VH150289ZR, H41212RS), VH150819MK (01008406821216511119050021VH150819MK, H41212ZC), VH150529PP (01008406821216511118120021VH150529PP, H41212ZC), VH150606XW (01008406821216511119090021VH150606XW, H41212ZC), VH1505755D (01008406821216511118120021VH1505755D, H41212ZC), VH150747UN (01008406821216511119032621VH150747UN, H41212ZC), VH200165ZC (01008406821216511120071421VH200165ZC, H41212ZC), VH200170IX (01008406821216511120071521VH200170IX, H41212ZC), VH200228SY (01008406821216511120071521VH200228SY, H41212ZC), VH200239FZ (01008406821216511120071621VH200239FZ, H41212ZC), VH200163VU (01008406821216511120071621VH200163VU, H41212ZC), VH150695BV (01008406821216511119032121VH150695BV, H41212ZC), VH150708AA (01008406821216511119032121VH150708AA, H41212ZC), VH150745T5 (01008406821216511119032121VH150745T5, H41212ZC), VH150754YW (01008406821216511119032121VH150754YW, H41212ZC), VH150286IC (01008406821216511118010021VH150286IC, H41212RS)

    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 (44 units of this model)