FDAFDA · Alimentos y medicamentos·N.º oficial Z-2120-2015
GE Healthcare Precision 500D Classical R & F system.
Publicado el 29 de julio de 2015 · Inicio del retiro: 12 de junio de 2015
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
A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare
- Distribuidor
- Worldwide Distribution - US Nationwide Distribution including GU and DC., and to the countries of : Australia, Bulgaria, Canada, Chile, Dominican Republic, Germany, Ireland, Italy, Kuwait, Lebanon, Portugal, Romania, Russia, Saudi Arabia, Slovakia, Spain, Taiwan,Turkey, United Kingdom, Venezuela and Yemen.
- Lote
- Mfg Lot or Serial # 00000002243MC4 00000017545MC9 00000001018MC1 00000001083MC5 00000003942MC0 00000001707MC9 00000001110MC6 0000000B2055KJ 00000001283MC1 00000002163MC4 00000002189MC9 00000002190MC7 00000000895MC3 00000001165MC0 00000001107MC2 00000004224MC2 00000001902MC6 00000004278MC8 00000000930MC8 00000000945MC6 00000004162MC4 00000004211MC9 00000001560MC2 00000001293MC0 00000003575MC8 00000003619MC4 00000001204MC7 00000001205MC4 00000003702MC8 00000003885MC1 00000001207MC0 00000004018MC8 00000001128MC8 00000004382MC8 00000004578MC1 00000001385MC4 00000003406MC6 00000000868MC0 00000000949MC8 00000001369MC8 00000003932MC1 00000001006MC6 00000001361MC5 00000001441MC5 00000000888MC8 00000001097MC5 00000003622MC8 00000001058MC7 00000004422MC2 00000001511MC5 00000001614MC7 00000001245MC0 00000003700MC2 00000003701MC0 00000001360MC7 00000001155MC1 00000001588MC3 00000003617MC8 00000002387MC9 00000003928MC9 00000001005MC8 00000001011MC6 00000003479MC3 00000001223MC7 00000001316MC9 00000001105MC6 00000003697MC0 00000001613MC9 00000000986MC0 00000001443MC1 00000001166MC8 00000002375MC4 00000001300MC3 00000004381MC0 00000000915MC9 00000002146MC9 00000003943MC8 00000001412MC6 00000001507MC3 00000001483MC7 00000001182MC5 00000004588MC0 00000003658MC2 00000001017MC3 00000001513MC1 00000002034MC7 00000002356MC4 00000000971MC2 00000004085MC7 00000003784MC6 00000001262MC5 00000001875MC4 00000004670MC6 00000003968MC5 00000001450MC6 00000001873MC9 00000004383MC6 00000004419MC8 00000004645MC8 00000001108MC0 00000001643MC6 00000001841MC6 00000000865MC6 00000004061MC8 00000001840MC8 00000001414MC2 00000001972MC9 00000001531MC3 00000001705MC3 00000001748MC3 00000001404MC3 00000001440MC7 00000001709MC5 00000001229MC4 00000000913MC4 00000001534MC7 00000001187MC4 00000001477MC9 00000004277MC0 00000002238MC4 00000003620MC2 00000003933MC9 00000001465MC4 00000001545MC3 00000002147MC7 00000002378MC8 00000003761MC4 00000002106MC3 00000004379MC4 00000001013MC2 00000001471MC2 00000001702MC0 00000004107MC9 00000003785MC3 00000001353MC2 00000003585MC7 00000001608MC9 00000001609MC7 00000004020MC4 00000002357MC2 00000003934MC7 00000001832MC5 00000001908MC3 00000004502MC1 00000002262MC4 00000002382MC0 00000001464MC7 00000001842MC4 00000004017MC0 00000001475MC3 00000004504MC7 00000002150MC1 00000002264MC0 00000001299MC7 00000004086MC5 00000001641MC0 00000002373MC9 00000001563MC6 00000001220MC3 00000001973MC7 00000001433MC2 00000001439MC9 00000004055MC0 00000018721MC1 00000001126MC2 00000001159MC3 00000000836MC7 00000001341MC7 00000001481MC1 00000001163MC5 00000002242MC6 00000003735MC8 00000001562MC8 00000001586MC7 00000004582MC3 00000000835MC9 00000002240MC0 00000002103MC0 00000002035MC4 00000001279MC9 00000001278MC1 00000001510MC7 00000004063MC4 00000002377MC0 00000002105MC5 00000002185MC7 00000003660MC8 00000001295MC5 00000001704MC6 00000001284MC9 00000001310MC2 00000003882MC8 00000001094MC2 00000001219MC5 00000000897MC9 00000003758MC0 00000000920MC9 00000001711MC1 00000003974MC3 00000003938MC8 00000002161MC8 00000000879MC7 00000001572MC7 00000003509MC7 00000001096MC7 00000003703MC6 00000004425MC5 00000004109MC5 00000004201MC0 00000001642MC8 00000000961MC3 00000001183MC3 00000001718MC6 00000002107MC1 00000001249MC2 00000000979MC5 00000004163MC2 00000002266MC5 00000002208MC7 00000004062MC6 0000004062MC6A 00000001752MC5 00000001976MC0 00000002383MC8 00000003698MC8 00000002036MC2 00000004579MC9 00000001189MC0 00000001425MC8 00000003407MC4 00000001719MC4 00000000976MC1 00000003939MC6 00000001130MC4 00000001260MC9 00000001624MC6 00000002148MC5 00000002358MC0 00000001090MC0 00000003409MC0 00000001874MC7 00000001362MC3 00000004276MC2 00000001489MC4 00000001088MC4 00000001398MC7 00000001905MC9 00000003507MC1 00000001716
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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