Z-0518-2022 Class II Terminated
Recalled by GE Healthcare, LLC
— Waukesha, WI
FDA device recall Z-0518-2022 was initiated by GE Healthcare, LLC on November 4, 2021 and is designated Class II. Reason for recall: 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 wi… The recall status is terminated (terminated July 24, 2026). Affected quantity: 12,526 total reported units (7 units of this model).
Recall Details
- Product Type
- Devices
- Report Date
- February 2, 2022
- Initiation Date
- November 4, 2021
- Termination Date
- July 24, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,526 total reported units (7 units of this model)
Product Description
GE Vscan Extend, being sold as "Vscan Extend Console"
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Information reads "Serial Number (UDI, Model Number)". VH1622261Y (01008406821216511118042621VH1622261Y, 5693455), VH161664XA (01008406821216511118031921VH161664XA, 5693455), VH2627194S (01008406821216511120071321VH2627194S, 5693455), VH160129E8 (01008406821216511117021721VH160129E8, 5693455), VH160834YQ (01008406821216511117110021VH160834YQ, 5693455), VH1642124F (01008406821216511119040921VH1642124F, 5693455), VH150152W7 (01008406821216511116080021VH150152W7, 5693455), VH160113JQ (01008406821216511117020321VH160113JQ, 5693455), VH161979EY (01008406821216511118030021VH161979EY, 5693455), VH162446PC (01008406821216511118061221VH162446PC, 5693455), VH161984GS (01008406821216511118030021VH161984GS, 5693455), VH161970GQ (01008406821216511118030021VH161970G, 5693455), VH1619899S (01008406821216511118030021VH1619899S, 5693455), VH160237FQ (01008406821216511117030021VH160237FQ, 5693455), VH1600005U (5693455), VH160007CX (5693455), VH160009UF (5693455), VH150153FK (5693455), VH161672SF (5693455), VH1624281N (5693455), VH150103AI (5693455), VH150150Z6 (5693455), VH160786JM (5693455), VH1608086P (5693455), VH1600107T (5693455), VH1607384V (5693455), VH1600112G (5693455), VH160012JB (5693455), VH1607406X (5693455), VH160742EX (5693455), VH1608215J (5693455), VH160633NC (5693455), VH160025HU (5693455), VH160744ZM (5693455), VH150151QA (5693455), VH160730NB (5693455), VH161629J2 (5693455), VH161631UU (5693455), VH160735W7 (5693455), VH161598QQ (5693455), VH1600189D (5693455), VH1501544T (5693455), VH160017E2 (5693455), VH150123AH (5693455), VH163240NI (5693455), VH160005HB (5693455), VH1656702Z (5693455), VH16567191 (5693455), VH1656729W (5693455), VH1656736Y (5693455), VH165674RL (5693455), VH165675AQ (5693455), VH165676D7 (5693455), VH1656777R (5693455), VH165678YC (5693455), VH165679H1 (5693455), VH150112VD (5693455), VH150113IF (5693455), VH1607343V (5693455), VH160012JB (5693455), VH150101S2 (5693455), VH160001S1 (5693455), VH160003N9 (5693455), VH1616079K (5693455), VH150105RI (5693455), VH150118BJ (5693455), VH1501144B (5693455), VH150119KV (5693455), VH150122PV (5693455), VH150104JE (5693455), VH150067PS (5693455), VH150102JE (5693455), VH16162756 (5693455), VH260391G7 (5693455), VH2609418F (5693455), VH26096618 (5693455), VH1600301G (5693455), VH160021FJ (5693455), VH160163HW (5693455)