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FDAFDA · Alimentos y medicamentos·N.º oficial Z-3081-2017

LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization. These microscopes are used for low magnification visualization during cataract, retina, and cornea surgeries

Publicado el 6 de septiembre de 2017 · Inicio del retiro: 25 de mayo de 2017

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

Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base.

Qué hacer

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Detalles del retiro

Fabricante
Alcon Research, Ltd.
Distribuidor
Worldwide Distribution - US (nationwide and Puerto Rico): Units were also distributed globally to the following countries: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzegovina, Bulgaria, Canada, Chile, Columbia, Costa Rica, Croatia, Curacao, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Ecuador, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hungary, India, Italy, Jamaica, Japan, Jordan, Kazakhstan, South Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, Ukraine, United Kingdom, and Uzbekistan
Lote
Domestic Serial Numbers: 1402548501X, 1402548502X, 1402548503X, 1402548504X, 1402548505X, 1402548506X, 1402577401X, 1402577402X, 1402577403X, 1402577404X, 1402577405X, 1402577406X, 1402612001X, 1402612002X, 1402612003X, 1402612004X, 1402612005X, 1402612006X, 1402655703X, 1402655704X, 1402655705X, 1402655706X, 1402705203X, 1402705204X, 1402728703X, 1402728704X, 1402728705X, 1402728706X, 1402804805X, 1402804806X, 1402887601X, 1402887602X, 1402887603X, 1402887604X, 1402959002X, 1402959004X, 1402959005X, 1402959006X, 1403012601X, 1403012602X, 1403012603X, 1403012604X, 1403012605X, 1403012606X, 1403045903X, 1403045904X, 1403045905X, 1403045906X, 1403072801X, 1403072802X, 1403072803X, 1403072804X, 1403072805X, 1403072806X, 1403124901X, 1403124902X, 1403124903X, 1403124904X, 1403124905X, 1403124906X, 1403145301X, 1403145302X, 1403145303X, 1403145304X, 1403145305X, 1403145306X, 1403173401X, 1403173402X, 1403173403X, 1403173404X, 1403173405X, 1403173406X, 1403211701X, 1403211702X, 1403211704X, 1403211706X, 1403239601X, 1403239602X, 1403239603X, 1403239604X, 1403239605X, 1403239606X, 1403253702X, 1403253703X, 1403253705X, 1403253706X, 1403272701X, 1403272702X, 1403351301X, 1403351302X, 1403351303X, 1403351304X, 1403351305X, 1403351306X, 1403390506X, 1403390803X, 1403390805X, 1403440402X, 1403440406X, 1403440502X, 1403440503X, 1403440505X, 1403440506X, 1403484502X, 1403484602X, 1403484603X, 1403484604X, 1403539702X, 1403539703X, 1403539704X, 1403539706X, 1403625401X, 1403625402X, 1403625403X, 1403625404X, 1403625405X, 1403625406X, 1403625501X, 1403625502X, 1403625504X, 1403625505X, 1403688701X, 1403688702X, 1403688801X, 1403688802X, 1403688803X, 1403688804X, 1403688805X, 1403688806X, 1403736301X, 1403736302X, 1403736303X, 1403736304X, 1403736305X, 1403736306X, 1403736401X, 1403736404X, 1403791801X, 1403791803X, 1403791805X, 1403791806X, 1403830904X, 1403830905X, 1403830906X, 1403831004X, 1403831005X, 1403831006X, 1403862204X, 1403862205X, 1403862206X, 1403862305X, 1403862306X, 1403886401X, 1403886402X, 1403886403X, 1403886404X, 1403886405X, 1403886406X, 1403886501X, 1403886502X, 1403886503X, 1403886504X, 1403886505X, 1403886506X, 1403986603X, 1403986604X, 1403986605X, 1403986606X, 1403990601X, 1403990602X, 1403990603X, 1403990604X, 1403990701X, 1403990703X, 1403990704X, 1403990705X, 1403990706X, 1404022104X, 1404022105X, 1404022202X, 1404022204X, 1501030401X, 1501030601X, 1501030606X, 1501088001X, 1501088006X, 1501088101X, 1501088105X, 1501088106X, 1501132903X, 1501132905X, 1501132906X, 1501158301X, 1501158302X, 1501158303X, 1501158304X, 1501158401X, 1501158402X, 1501158403X, 1501158404X, 1501158406X, 1501201501X, 1501201506X, 1501274503X, 1501355602X, 1501355603X, 1501355604X, 1501355605X, 1501355606X, 1501355702X, 1501565905X, 1501566001X, 1501566003X, 1501566004X, 150156600SX, 1501566006X, 1501619502X, 1501619503X, 1501619506X, 1501619601X, 1501619604X, 150161960SX, 1501619606X, 1501646804X, 1501646902X, 1501646903X, 1501646906X, 1501672006X, 1501672102X, 1501672105X, 1501672106X, 1501731601X, 1501731602X, 1501731604X, 1501731805X, 1501731806X, 1501790001X, 1501790002X, 1501790003X, 1501790004X, 1501790005X, 1501790006X, 1501790103X, 1501790104X, 1501790105X, 1501790106X, 1501838401X, 1501838402X, 1501838403X, 1501838404X, 1501838405X, 1501838406X, 1501898901X, 1501898902X, 1501898903X, 1501898904X, 1501898905X, 1501899003X, 1501899006X, 1501940101X, 1501940102X, 1501940104X, 1501940105X, 1501940106X, 1501955601X, 1501955602X, 1501955603X, 1501955604X, 1501955605X, 1502051002X, 1502051004X, 1502051006X, 1502134606X, 1502134701X, 1502134703X, 1502134705X, 1502176206X, 1502326701X, 1502326702X, 1502384602X, 1502384603X, 1502384605X, 1502384606X, 1502384705X, 1502384706X, 1502443501X, 1502443503X, 1502443504X, 1502443506X, 1502459501X, 1502459502X, 1502459601X, 1502459603X, 1502459604X, 1502473801X, 1502473802X, 1502473803X, 1502473804X, 1502473805X, 1502473806X, 1502473904X, 1502473905X, 1502499501X, 1502499504X, 1502499505X,
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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