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Nombre Fecha Fecha de inicio País Fuente
Alerta De Seguridad para Commercial name: Angiography equipment Artis. Technical Name: Angiography Equipment. ANVISA registration number: 10345162023. Risk class: III. Model affected: Artis Zee ceiling. Serial numbers affected: 17582 2017-10-19 Brazil ANVISA
Alerta De Seguridad para Trade name: Ingenuity CT. Technical name: CT Scanner. ANVISA registration number: 10216710209. Risk class: III. Model Affected: Ingenuity CT / Ingenuity Flex. Serial numbers affected: 52010, 31001, 52031, 52044, 52050, 52066, 310362, 310375, 338003, 32054, 32065, 32067, 52049, 336213, 52073, 30035, 30023, 52062, 32045, 30024 2017-10-16 Brazil ANVISA
Alerta De Seguridad para Trade name: Crepe bandage. Technical name: Crepom bandage. ANVISA registration number: 80603910003. Hazard class: I. Model affected: 12X1,20M 9 WIRE. Serial numbers affected: 1700101 2017-10-13 Brazil ANVISA
Notificaciones De Seguridad De Campo acerca de plum xl infusion pump family. 2011-04-01 Poland ORMPMDBP
Alerta De Seguridad para Name: Anesthesia System Carestation. Technical Name: Anesthesia Device. ANVISA registration number: 80071260356. Class of risk: III. Affected Model: Carestation 620, Carestation 650, Carestation 650C. Affected serial numbers: Carestation 620, Carestation 650, Carestation 650C (ANVISA Register 80071260356) 2017-10-26 Brazil ANVISA
Alerta De Seguridad para Brand name: Hemodialysis Catheter - Eagle Flow. Technical Name: Catheter. ANVISA registration number: 80120820020. Risk class: IV. Model Affected: HMP-3-20-SSK. Serial numbers affected: 1612031; 1612018 2017-11-01 Brazil ANVISA
Alerta De Seguridad para Commercial Name: Polar Fix Crepe Bandage. Technical name: Bandages. ANVISA registration number: 8003400027. Risk class: I. Model affected: 10cm x 1,80m. Serial numbers affected: 5436.01.03 2017-11-01 Brazil ANVISA
Alerta De Seguridad para Trade name: BC Thrombin Reagent. Technical Name: Thrombin Time (TT). ANVISA registration number: 10345161613. Class of risk: II. Affected model: Reagent: 10 x 5 mL (lyophilized) / Buffer solution: 1 x 50 mL. Serial numbers affected: 46751, 47184 2017-11-09 Brazil ANVISA
Alerta De Seguridad para Trade name: Somatom Definition AS. Technical name: CT Scanner. ANVISA registration number: 10345161981. Risk class: III. Affected model: Somatom Definition AS. Serial numbers affected: 64127; 64147; 64584; 64665; 64948; 64981; 64988; 65055; 65160; 65227; 65395; 5405; 65422; 65431; 65552; 65571; 65584; 65585; 65648; 65675; 65682; 65901; 65910; 65950; 65987; 66149; 66397; 66401; 66430; 66459; 66479; 66488; 6492; 66524; 66584; 66586; 66590; 66782 2017-11-09 Brazil ANVISA
Alerta De Seguridad para Trade name: Innova Over the Wire - Self-expanding Stent. Technical Name: Stent for Peripheral Arteries. ANVISA registration number: 10341350762. Class of risk: III. Model affected: Innova 180mm; Innova 20mm. Serial numbers affected: 17360209; 17363938; 17369922; 17468906; 17393388; 17379139; 17339472; 17389600; 17349970; 17515256; 17631664; 17717276; 17567309; 17363935; 17400326; 17733644; 17759557; 17779595; 17751229; 17692709; 17563580; 17515257; 17751231; 17879723; 17933183; 17645316; 17837622; 17884340; 17918022; 17977931; 18002828; 17993487; 17351561; 18004286; 18008900; 18010628; 17916568; 17968687; 18065189; 18025896; 18045282; 18006854; 18010629; 17951215; 18151350; 17959306; 18085879; 18065191; 18010625; 18085873; 18320374; 18028548; 18065193; 18194261; 18261826; 18270159; 17842281; 17933192; 18193713; 17507374; 18305612; 18350856; 18360974; 18242556; 17672511; 17974380; 18251442; 18205490; 18320373; 18028547; 18261827; 18311336; 18412269; 18290109; 18268062; 18356937; 18320365; 18393665; 18305640; 18412264; 18242554; 18431548; 18305613; 18412278; 18447004; 18530138; 17565344; 18463399; 18045281; 18587999; 18505164; 17349971; 18412270; 18463751; 18363018; 18074216; 17900991; 18320379; 18363017; 18572704; 18523620; 18431551; 18592948; 18488417; 18775746; 18920644; 18708475; 18771905; 18523626; 18505175; 18813754; 18065192; 18708601; 18530131; 18838475; 18838474; 18598903; 18010634; 18999958; 18713953; 18813758; 18478732; 18972076; 18972078; 18,754,507; 19105369; 18682281; 17360218; 19021789; 19129190; 18591335; 18881999; 19134315; 19039522; 19178740; 19048097; 19155962; 19129192; 19139328; 18628195; 19129188; 18785731; 19178742; 19129191; 19406217; 19367657; 19454503; 19079547; 18934945; 19426951; 18751467; 19458596; 19237436; 19574803; 18802852; 19684641; 19178744; 19105371; 19178747; 19469659; 19602765; 19597809; 19654093; 19728400; 18892416; 19699232; 20013954; 19858438; 20013951; 20084781; 19664962; 19597807; 19786768; 19129193; 20013953; 20089472; 20149243; 20133564; 20205065; 20313037; 20233662; 19212926; 19238403; 20234802; 20013943; 20223203; 20176442; 20210386; 19775531; 19039533; 19294321; 20244724; 20410523; 20347584; 20042126; 19984995; 20316577; 19946630; 20303720; 20109694; 20234804; 20427173; 20127894; 20313036; 19946636; 20303721; 20642269; 20589399; 20042120; 20478645; 19907848; 20247006; 20171185; 20791401; 20557178 2017-11-10 Brazil ANVISA
Alerta De Seguridad para Commercial name: Ergo Stereotactic Planning System. Technical Name: Software de Planej. of Trat. P / Radiation therapy. ANVISA registration number: 80569320022. Risk class: III. Affected Model: ERGO ++ Radiation Treatment Planning Software (+ Localyzer). Serial numbers affected: 1.7.3, 1.7.5, 1.7.7, 1.7.8 2017-11-10 Brazil ANVISA
Alerta De Seguridad para Commercial name: Nuclear Imaging System. Technical name: Nuclear Imaging System. ANVISA registration number: 10310650051. Risk class: III. Affected model: Millennium VG, Discovery VH, Varicam. Serial numbers affected: Millennium VG, Discovery VH, Varicam 2017-11-13 Brazil ANVISA
Alerta De Seguridad para Trade name: Infusion Pump. Technical Name: Infusion Pump. ANVISA registration number: 80113010024. Risk class: III. Model Affected: Infusion Pump GH / Infusion Pump PK. Serial numbers affected: pumps manufactured prior to September / 2008 - attached list. 2017-11-16 Brazil ANVISA
Alerta De Seguridad para Trade name: DBS Electrode for Deep Brain Stimulation. Technical Name: CABLE / ELECTRODE FOR DEEP BRAIN ELECTRIC STIMULATION SYSTEM. ANVISA registration number: 10339190484. Class of risk: IV. Model Affected: 3387 / 3387-28 / 3387-40 / 3387S / 3387-40. Serial numbers affected: see attachment 2017-11-16 Brazil ANVISA
Alerta De Seguridad para Commercial Name: Atlas Gold Dilatation Catheter. Technical name: Columbus rev. Spacer Fémoral post.f6 15mm / Columbus rev. Spacer Fémoral post. f7 15mm. ANVISA registration number: 80136990668. Risk class: III. Model Affected: NR586K / NR587K. Serial numbers affected: Code NR586K: 51586634 and 51447596; Code NR587K: 51585136 and 51447597 2017-11-10 Brazil ANVISA
Alerta De Seguridad para Commercial Name: Atlas Gold Dilatation Catheter. Technical name: Balloon catheter for peripheral angioplasty. ANVISA registration number: 80689090119. Class of risk: II. Model Affected: ATG120164 / ATG120202 / ATG120242. Serial numbers affected: 93NB0051 / 93NB0052 / 93YA0086 / 93YA0036 2017-10-30 Brazil ANVISA
Alerta De Seguridad para Trade name: Prime and Bond 2.1. Technical Name: Adhesion / Silanization Agent. ANVISA registration number: 10186370053. Class of risk: II. Model affected: n / a. Serial numbers affected: lot 212628I, to which it generated the finishing batches: 220581I, 225656I and 228030I 2017-11-23 Brazil ANVISA
Alerta De Seguridad para Product name: Acrous ultra fast sterilizer //. Technical Name: Sterilizer //. ANVISA registration number: 80511600003 //. Risk class: II - Medium Risk //. Model affected: UR3 //. Serial Numbers Affected: ALL - See Distribution Map 2017-11-29 Brazil ANVISA
Alerta De Seguridad para Acuvue Advance. Technical Name: Contact Lenses. ANVISA registration number: 80148620026. Class of risk: II. Model Affected: N / A. Serial numbers affected: B00DHLP 2017-11-27 Brazil ANVISA