GE Vscan Extend recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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)

Product

GE Vscan Extend, being sold as "Vscan Extend Console"

Recalling firm

GE Healthcare, LLC

Quantity

12,526 total reported units (7 units of this model)

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.

Recall date

February 2, 2022

Classification

Class II

Status

Terminated

Agency

FDA (device)