FDAFDA · Alimentos y medicamentos·N.º oficial Z-0522-2022
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
Publicado el 2 de febrero de 2022 · Inicio del retiro: 4 de noviembre de 2021
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- 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.
- Lote
- Information reads "Serial Number (UDI, Model Number)". VH200176M2 (01008406821216511120080721VH200176M2, H41212ZD), VH150224FV (01008406821216511117040421VH150224FV, H41212RT), VH150359UT (01008406821216511118020021VH150359UT, H41212RT), VH150510JG (01008406821216511118110021VH150510JG, H41212ZD), VH150725FX (01008406821216511119031521VH150725FX, H41212ZD), VH150726PL (01008406821216511119031521VH150726PL, H41212ZD), VH150833LB (01008406821216511119050021VH150833LB, H41212ZD), VH2004729L (01008406821216511120122221VH2004729L, H41212ZD), VH200602E1 (01008406821216511121031021VH200602E1, H41212ZD), VH2007327J (01008406821216511121062921VH2007327J, H41212ZD), VH1504296K (01008406821216511118070021VH1504296K, H41212ZD), VH2001141J (01008406821216511120010021VH2001141J, H41212ZD), VH200727M4 (01008406821216511121061421VH200727M4, H41212ZD), VH200416DE (01008406821216511120111221VH200416DE, H41212ZD), VH1505184H (01008406821216511118120021VH1505184H, H41212ZD), VH200022GP (01008406821216511119120021VH200022GP, H41212ZD), VH150208XB (01008406821216511117040421VH150208XB, H41212RT), VH200663IW (01008406821216511121061521VH200663IW, H41212ZD), VH2006663X (01008406821216511121061521VH2006663X, H41212ZD), VH20071415 (01008406821216511121061721VH20071415, H41212ZD), VH200719LG (01008406821216511121061521VH200719LG, H41212ZD), VH150488AN (01008406821216511118110021VH150488AN, H41212ZD), VH200092VS (01008406821216511120010021VH200092VS, H41212ZD), VH200158ZR (01008406821216511120020021VH200158ZR, H41212ZD), VH20078872 (01008406821216511121072321VH20078872, H41212ZD), VH150329VP (01008406821216511118021321VH150329VP, H41212RT), VH200042EG (01008406821216511119120021VH200042EG, H41212ZD), VH1501645D (01008406821216511117052321VH1501645D, H41212RT), VH20049973 (01008406821216511120122221VH20049973, H41212ZD), VH150627JD (01008406821216511119012121VH150627JD, H41212ZD), VH1510213I (01008406821216511119110021VH1510213I, H41212ZD), VH200078CB (01008406821216511119120021VH200078CB, H41212ZD), VH200086VZ (01008406821216511120010021VH200086VZ, H41212ZD), VH200104JD (01008406821216511120030021VH200104JD, H41212ZD), VH2001402U (01008406821216511120020021VH2001402U, H41212ZD), VH200604XJ (01008406821216511121022421VH200604XJ, H41212ZD), VH20076953 (01008406821216511121072221VH20076953, H41212ZD), VH200772N5 (01008406821216511121072221VH200772N5, H41212ZD), VH150304YL (01008406821216511118020221VH150304YL, H41212RT), VH1504811P (01008406821216511118102221VH1504811P, H41212ZD), VH150483QI (01008406821216511118110121VH150483QI, H41212ZD), VH150486BT (01008406821216511118110121VH150486BT, H41212ZD), VH150487IA (01008406821216511118110421VH150487IA, H41212ZD), VH150717E8 (01008406821216511119031321VH150717E8, H41212ZD), VH150524EK (01008406821216511118120021VH150524EK, H41212ZD), VH150814W4 (01008406821216511119050021VH150814W4, H41212ZD), VH150815EB (01008406821216511119050021VH150815EB, H41212ZD), VH1508226B (01008406821216511119050021VH1508226B, H41212ZD), VH1508233A (01008406821216511119050021VH1508233A, H41212ZD), VH1509599D (01008406821216511119060021VH1509599D, H41212ZD), VH200035ND (01008406821216511119120021VH200035ND, H41212ZD), VH200439SJ (01008406821216511120120921VH200439SJ, H41212ZD), VH200668T6 (01008406821216511121061521VH200668T6, H41212ZD), VH200681YL (01008406821216511121061421VH200681YL, H41212ZD), VH2007231C (01008406821216511121061421VH2007231C, H41212ZD), VH200724YY (01008406821216511121061521VH200724YY, H41212ZD), VH200820FQ (01008406821216511121091721VH200820FQ, H41212ZD), VH150631WK (01008406821216511119030021VH150631WK, H41212ZD), VH1506566S (01008406821216511119030021VH1506566S, H41212ZD), VH150666EB (01008406821216511119030021VH150666EB, H41212ZD), VH150694FG (01008406821216511119030021VH150694FG, H41212ZD), VH150705HV (01008406821216511119030021VH150705HV, H41212ZD), VH1503974U (01008406821216511118050021VH1503974U, H41212ZD), VH15096421 (01008406821216511119070021VH15096421, H41212ZD), VH200777KC (01008406821216511121081621VH
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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