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Nombre Fecha Fecha de inicio País Fuente
Alerta De Seguridad para Trade Name: Transfer Kit for Exactamix. Technical Name: Transfer Kit for Exactamix. ANVISA registration number: 80145240403. Class of Risk: II. Affected Model: H938173 | H938174 | H938175 | H938176. Serial numbers affected: 802385 | 802279 | 802281 | 802284 2018-05-23 Brazil ANVISA
Alerta De Seguridad para Trade Name: Sterile Operating Field Technical Name: Surgical Field ANVISA Registration Number: 8003740007 Hazard Class: II Model Affected: Sterile Operating Field 25X28CM Serial Numbers Affected: LOT: 034-2 FAB: 3/19/2018. 2018-05-23 Brazil ANVISA
Alerta De Seguridad para Commercial Name: Computed Tomography System / CT Scanner. Technical Name: Computerized Tomographic Equipment. ANVISA registration number: 80071260079. Risk Class: III. Affected Model: Optima CT 540, BRIGHTSPEED ELITE 16 SLICE EDITION, Optima CT 540 Mobile, OPTIMA CT 660, REVOLUTION EVO, Optima CT 660 Cj 3.5 (80071260119 and 80071260079). Serial numbers affected: CJRAX1600072CN; CJRAX1700001CN; CJRAX1700002CN; CJRMX1600005CN; JRMX1600011CN; CJRMX1600012CN; CJRMX1600013CN; CJRMX1600014CN; CJRMX1600018CN; CJRMX1600019CN; 00000030120YC0; 00000030500YC3; 00000033404YC5; 00000033973YC9; 00000035290YC6; 00000428317CN2; 00000429355CN1; 00000429530CN9; 00000437168CN8; 00000437278CN5; 00000441652CN5; 00000441968CN5; CBAQG1600010HM. 2018-05-25 Brazil ANVISA
Alerta De Seguridad para Trade Name: MagNA Pure 24 System. Technical Name: Instrument for analysis of nucleic acids. ANVISA registration number: 10287411309. Risk Class: II. Model Affected: N / A. Serial numbers affected: Active: 1119 | Inventory: 1162 2018-05-28 Brazil ANVISA
Alerta De Seguridad para Commercial Name: Angiography Equipment Artis. Technical Name: Angiography Equipment. ANVISA registration number: 10345162023. Risk Class: III. Model affected: Artis zee ceilling; Artis zeego. Serial numbers affected: 147619; 160836; 160843 2018-05-28 Brazil ANVISA
Alerta De Seguridad para Trade Name: Harmonic Ace Shears and Adaptive Tissue Technology. Technical Name: Electrosurgical Cable (Power greater than 50W). ANVISA registration number: 80145901455. Risk Class: III. Model affected: HAR23; HAR36. Affected Serial Numbers: Codes and batch numbers related to each code, for individually marketed affected products, and for kits containing affected products are shown in the Customer Letter attached to this Alert. 2018-05-29 Brazil ANVISA
Alerta De Seguridad para Business Name: Heartware - Ventricular Assist System. Technical Name: Intracardiac Pump. ANVISA registration number: 10339190685. Risk Class: IV. Affected Model: All components that are part of the Heartware Ventricular Assist System. Serial numbers affected: bat013046; bat013114; BAT013820; BAT013825; BAT014350; BAT014351; BAT014352; BAT014353; BAT015058; BAT015059; BAT015060; BAT015061; BAT015062; BAT015065; BAT015066; BAT015070; BAT030136; BAT030210; BAT030245; BAT030247; BAT091007; BAT091113; BAT091133; BAT091137; BAT091139; BAT092750; BAT092755; BAT092781; BAT092793; BAT092795; BAT092802; BAT092807; BAT200397; BAT200399; BAT200479; BAT200484; BAT200488; BAT200519; BAT200550; BAT200552; BAT200621; BAT200678; BAT200720; BAT200771; BAT200772. 2018-05-30 Brazil ANVISA
Alerta De Seguridad para Trade Name: Intra-Aortic Balloon Pump. . Technical Name: Intra-Aortic Balloon Pump System. . ANVISA registration number: 10390690062.. Risk Class: III. . Model affected: CARDIOSAVE. . Serial numbers affected: CH207880C5; CH245699K6 2018-05-30 Brazil ANVISA
Alerta De Seguridad para Trade Name: Bardport Port Fully Implantable in Titanium and Silicon; Fully Implantable Bardport in Plastic and Silicone; Port Implanted X-Port Isp with Silicone Catheter and Peel-Apart Bard Introducer Kit; Powerport Chronoflex Open End Mri; Powerport Catheter Groshong Valvular Mri. Technical Name: Infusion Catheter; Infusion Port Catheter. ANVISA registration number :. 80689090126; 80689090128; 80689090136; 80689090103; 80689090105. Hazard Class: IV. Affected model: Titanium Ports (base diameter: 31.7 mm, height: 14.5 mm, weight: 15.4 g); Port Titanium Dome (base diameter: 27.2 mm, height: 15 mm, weight: 7.9 g); MRI Ports Low Profile (base diameter: 24.8 mm, height: 10 mm, weight: 3.2 g); connectable; 8 Fr - Polyurethane catheter without suture plug; 8F MRI without suture plug, single lumen .. Serial Numbers Affected: Code Lot Number: 0602240 REBT0050; 0602850 REBT0345; 0603870 REBT2330; 0607555 REBT2153; 0607555 REBV1315; 8808061 REBU0499; 8808561 REBU1200 2018-06-04 Brazil ANVISA
Alerta De Seguridad para Identification of the product or case :. Trade Name: BD Posiflush Heparin Lock Flush Syringe. Technical Name: Disposable Syringes. Registration number ANVISA: 10033430366. Class of Risk: IV. Affected model: BD Posiflush Syringe with Heparin, USP, 300 units / 3mL (100 units / mL) - 3mL in 10mL syringe. Serial numbers affected: Lots #: 708782N and 709772N. 2018-06-04 Brazil ANVISA
Alerta De Seguridad para Commercial Name: Prismaflex Monitor. Technical Name: Prismaflex Control Unit. ANVISA registration number: 80145240438. Risk Class: III. Affected Model: 955052, 114489, 107493 and 113082. Serial numbers affected: See Attached List, Attachment 1 2018-06-04 Brazil ANVISA
Alerta De Seguridad para Trade Name: Load for Endo Gia Universal Stapler with Tri-Staple Technology. Technical Name: Clamps. ANVISA registration number: 10349000296. Class of Risk: III. Model Affected: EGIA45AMT; EGIA45AVM; EGIA45AXT; EGIA60AMT; EGIA60AXT; EGIA60AXT; EGIA45AMT; EGIA45AVM; EGIA60AMT; EGIA45AXT. Serial numbers affected: N7L1057KX; N7L0551KX; N7M0877KX; N8A0146KX; N8A0907KX; N8A0488KX; N7M0853KX; N7M0486KX; N7L0974KX; N8A0363KX; N7L0521KX; N7L1038KX 2018-06-04 Brazil ANVISA
Alerta De Seguridad para Trade Name: Articular Cannulas with MAQUET Reinforcement. Technical Name: Cannulae. ANVISA registration number: 10390690100. Risk Class: IV. Affected Model: Articular Cannulas with MAQUET Reinforcement. Serial numbers affected: A202107; A222107; A242107; ACR0890V; ACR1890V; AS18V; AS21V; AS24V 2018-06-04 Brazil ANVISA
Notificaciones De Seguridad De Campo acerca de obligatory update of some versions of pentacam® axl software 2018-01-15 Poland ORMPMDBP
Notificaciones De Seguridad De Campo acerca de 3m for disposable surgical gowns and reinforced disposable surgical gowns 3m 2009-03-27 Poland ORMPMDBP
Notificaciones De Seguridad De Campo acerca de 3m steri-drape surgical drapes and 3m steri-drape surgical drape kits 2012-07-20 Poland ORMPMDBP
Notificaciones De Seguridad De Campo acerca de battery management tools for fortify, fortify assura, quadra assura, quadra assura mp, unify, unify assura and unify quadra implantable cardioverter defibrillators 2017-09-01 Poland ORMPMDBP
Notificaciones De Seguridad De Campo acerca de bioresorbable vascular scaffold systems absorb bioresorbable vascular scaffold and absorb gt1 bvs syste 2015-12-07 Poland ORMPMDBP
Notificaciones De Seguridad De Campo acerca de clinical chemistry reagents urea nitrogen with lot numbers 97642un11 and 97668un11. 2011-10-10 Poland ORMPMDBP
Notificaciones De Seguridad De Campo acerca de ctni cassettes for the i-stat blood analyzer 2012-07-20 Poland ORMPMDBP
Notificaciones De Seguridad De Campo acerca de falsely elevated architect estradiol test results in samples from patients receiving fulvestrant 2016-04-07 Poland ORMPMDBP
Notificaciones De Seguridad De Campo acerca de handling centrimag circulating system power cable for emergency use, model: 201-10002, 2018-09-11 Poland ORMPMDBP
Notificaciones De Seguridad De Campo acerca de implantable fortify, fortify assura, quadra assura, quadra assura mp, unify, unify assura and unify quadra cardioverter-defibrillators 2018-05-10 Poland ORMPMDBP
Notificaciones De Seguridad De Campo acerca de implantable pulse generator nm 2017-10-02 Poland ORMPMDBP
Notificaciones De Seguridad De Campo acerca de implantable pulse generator nm 2017-09-29 Poland ORMPMDBP