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Nombre Fecha Fecha de inicio País Fuente
Alerta De Seguridad para INSTRUMENTAL NON-JOINT NON-ROLLER, Model RIA Locking Clamp - Single Size, Registration No. 80145901733. Code: 352.260S, Lot 2671884 2015-11-12 Brazil ANVISA
Alerta De Seguridad para Computed tomography system, Revolution CT model, risk class III, registration 80071260343. All equipment with software version 15MW03.12. 2015-11-04 Brazil ANVISA
Alerta De Seguridad para Macrogotes Equipment for Intravenous Infusion, Registration nº 10330669065, lot: SEMN088, Val. Dec./2018 2015-10-02 Brazil ANVISA
Alerta De Seguridad para Macrogots for Intravenous Infusion-SLIP, lot SEML 024-SEP / 2013 2015-08-10 Brazil ANVISA
Alerta De Seguridad para Ultrasound Video Endoscopy Evis Exera II, Brand: Olympus, Model GF-UCT-180; Registration: 80124630028, Serial numbers: 1511308,1511310,1110516, 1311111, 1100184, 1110285, 1110490, 1110518, 1411230, 1411254, 1411252, 1411267, 1411270, 1411271, 1411293. 2015-12-02 Brazil ANVISA
Alerta De Seguridad para Equipment for angiography ALLURA XPER, brand PHILIPS, Risk class: III, model: ALLURA XPER FD10 (floor), ALLURA XPER FD10 (ceiling), ALLURA XPER FD20 (floor), ALLURA XPER FD20 (ceiling), Registry: 10216710153; ///// ALLURA XPER ANGIOGRAPHY EQUIPMENT, model: ALLURA XPER FD10 / 10; ALLURA XPER FD20 / 10; ALLURA XPER FD20 / 20; ALLURA XPER FD 20/15; ALLURA XPER FD10 / 10 OR Table; ALLURA XPER FD20 / 10 OR Table; ALLURA XPER FD20 / 20 OR Table; ALLURA XPER FD 20/15 OR Table .. risk class III, registration 10216710206. 2015-11-09 Brazil ANVISA
Alerta De Seguridad para Equipment for angiography ALLURA XPER, brand PHILIPS, Risk class: III, model: ALLURA XPER FD10 (floor), ALLURA XPER FD10 (ceiling), ALLURA XPER FD20 (floor), ALLURA XPER FD20 (ceiling), Registry: 10216710153; ///// ALLURA XPER ANGIOGRAPHY EQUIPMENT, model: ALLURA XPER FD10 / 10; ALLURA XPER FD20 / 10; ALLURA XPER FD20 / 20; ALLURA XPER FD 20/15; ALLURA XPER FD10 / 10 OR Table; ALLURA XPER FD20 / 10 OR Table; ALLURA XPER FD20 / 20 OR Table; ALLURA XPER FD 20/15 OR Table .. hazard class III, registration 10216710206. /// Serial numbers: 722006; 722124. 2015-11-09 Brazil ANVISA
Alerta De Seguridad para Retention Disposable Syringe 3mL Sol-Ject, Registration No. 10362890035, lot: 10102201C 2015-07-31 Brazil ANVISA
Alerta De Seguridad para Angiography Equipment Allura Xper. Model (s): FD10 (floor); FD10 (ceiling); FD20 (ground); FD20 (ceiling); FD10 OR Table; FD20 OR Table; FD10 / 10; FD20 / 20; FD20 / 10; FD10 / 10 OR Table; FD20 / 20 OR Table; FD20 / 10 OR Table. Anvisa Registry n ° 10216710153. 2015-11-18 Brazil ANVISA
Alerta De Seguridad para Hypodermic Needle Solidor - Registration 10237580042 - Risk Class: II - Medium Risk - Lot BE30G / 14D01 - The lot was commercialized for the Municipal Health Fund of São Paulo and for the company Elza Maria Magalhães Torres - ME, from Belém / PA 2015-10-30 Brazil ANVISA
Alerta De Seguridad para VARIOUS PRODUCTS /// 1.Commercial Name: Knee Prosthesis - Registration: 10108770064 - Risk Class: III - Models and Lots in ANNEX; /// 2.Commercial Name: Spongy Screw - Registration: 10108770074 - Risk Class: III - Models and Lots in ANNEX; /// 3. Trade Name: Shoulder Prosthesis - Registration: 10108770083 - Risk Class: III - Models and Lots in ANNEX; /// 4. Trade Name: NON-CONVENTIONAL ENDOPROTES FOR TIBIA, FEMUR OR UMERO - Registration: 10108770086 - 5. PRODUCT NAME: FEMALE COMPONENT IMPOL - Registration: 10108770089 - Risk Class: III - Models and Lots in ANNEX; /// 6. Trade Name: FEMALE COMPONENT IMPOL - Registration: 10108770089 - Risk Class: III - Models and Lots in ANNEX; /// 7. Trade Name: SLIDING SCREW - Registration: 10108770090 - Risk Class: III - Models and Lots in ANNEX; Name of Product: Tibial Metallic Base - Registration: 10108770091 - Risk Class: III - Models and Lots in ANNEX; /// 9. Trade Name: CORTICAL SCREW - Registration: 10108770092 - Risk Class: III - Models and Lots in ANNEX; /// 10. Trade Name: PLACA TUBO LARGE FRAGMENTS - Registration: 10108770094 - Risk Class: III - Models and Lots in ANNEX; /// 11. Trade Name: RETAIL PLATE - Registration: 10108770095 - Risk Class: III - Models and Lots in ANNEX; /// 12. Trade Name: MODULAR FEMALE HEAD IN STEEL - Registration: 10108770096 - Hazard Class: III - Model and Lots in ANNEX; /// 13. Trade Name: PROTEIN OF ELBOW FOR ARTHROPLASTY UMERO-ULNAR TOTAL CEMENTED - Registration: 10108770097 - Risk Class: III - Models and Lots in ANNEX; /// 14. Trade Name: Intramedine haste BLOCKED - Registration: 10108770099 - Risk Class: III - Models and Lots in ANNEX; /// 15. Trade Name: MODIFIED CEMENT FEMALE STEM - Registration: 10108770106 - Risk Class: III - Models and Lots in ANNEX; // 16. Trade Name: ACETABULAR COMPONENT IN CEMENTED POLYETHYLENE - Registration: 10108770107 - Risk Class: III - Models and Lots in ANNEX; /// 17. Trade Name: System for total knee prosthesis - Registration: 10108770108 - Class of Risk: III - Models and Lots in ANNEX; /// 18. Trade Name: SYSTEM FOR PARTIAL ARTHROPLASTY V GENERATION - Registration: 10108770109 - Hazard Class: III - Models and Lots in ANNEX; /// 19. Trade Name: POLYMERIC ACETABULAR NUCLEUS WITH METALLIC JOINT SURFACE - Registration: 10108770111 - Hazard Class: III - Models and Lots in ANNEX ; /// 20. Trade Name: PINO DE SCHANZ - Registration: 10108770114 - Risk Class: III - Models and Lots in ANNEX; /// 21. Trade Name: Head for Integral Shoulder Arthroplasty - Registration: 10108770115 - Class of /// 22. Trade Name: FIXATION SYSTEM FOR THE LARGE AND SMALL SPACES OF STAINLESS STEEL FRAGMENTS - IMPOL - Registration: 10108770117 - Risk Class: III - Models and Lots in ANNEX ; /// 23. Trade Name: ENDOPROTESES INFERIOR MEMBERS EUROTOP - Registration: 10108770118 - Risk Class: III - Models and Lots in ANNEX; /// 24. Trade Name: Modular System for Shoulder Arthroplasty Eccentra II - Registry: 10108770122 - Risk Class: III - Models and Lots in ANNEX; / 25. Trade Name: INSERTO TIBIAL - IMPOL - Registration: 10108770123 - Class of Risk: III - Models and Lots in ANNEX; /// 26. Trade Name: INSERTO TIBIAL - IMPOL - Models and Lots in ANNEX; /// 27. Trade Name: Large and Small Blocked Regional Special Panels System - Impol - Registration: 10108770125 - Risk Class: III - Models and Lots in ANNEX; /// 2015-11-19 Brazil ANVISA
Alerta De Seguridad para Product: Pacemaker Cardiac Resynchronization Therapy (M-CRT) InSync III. Model (s): 8042, 8042B and 8042U. Anvisa Registry n ° 10339190158. 2015-11-20 Brazil ANVISA
Alerta De Seguridad para Product: AMPHIRION DEEP OTW - PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. Anvisa registration No. 10339190532. Products affected: AMD015020002 AMD020120152 AMD025150152 AMD030150152 AMD040120002 AMD335210002 AMD015020151 AMD020150002 AMD030040002 AMD035040152 AMD040120152 AMD335210152 AMD015020152 AMD020150152 AMD030040152 AMD035120002 AMD040150002 AMD354210002 AMD020040002 AMD025040152 AMD030080002 AMD035150002 AMD040150152 AMD354210152. AMD020040152 AMD025080152 AMD030080152 AMD035150152 AMD225210002. AMD0200120002 AMD025120002 AMD030120002 AMD040040152 AMD225210152. AMD0200160152 AMD025120152 AMD030120152 AMD040080002 AMD253210002. AMD02012002 AMD025150002 AMD030150002 AMD040080152 AMD253210152 ... #### UPDATE (01/14/2016): According to the company, all the codes of the products affected globally were erroneously reported, but in Brazil only one code was affected (AMD225210152), of which only 03 lots are under risk - 209532760, 209507756 and 209507757. The above list (see above) does not therefore apply in its entirety to Brazil. 2015-11-20 Brazil ANVISA
Alerta De Seguridad para Product: Intracranial Clip for Brain Aneurysm - ADCA Titanium. Model (s): Standard Fenestrado 3,5mm. Anvisa Registry n ° 80116050002. Products under risk: Lot 0265-2015 (manufactured 05/13/2015) and lot 0266-2015 (manufactured 05/05/2015). 2015-11-20 Brazil ANVISA
Alerta De Seguridad para Product: Angiographic catheter with hydrophilic surface. Model (s): SCBR4.0-35-150-P-NS-O. Registro Anvisa n °: 10212990249./// On 12/01/2015 - added new lots for the collection: 4350176; 4552616; 4,598534; 4594005; 5,459,289; 4,582479 and 4604577. 2015-11-21 Brazil ANVISA
Alerta De Seguridad para Product: Angiographic catheter with hydrophilic surface. Model (s): SCBR4.5-35-75-P-NS-ANG-SHTL. Registro Anvisa n °: 10212990249. 2015-11-21 Brazil ANVISA
Alerta De Seguridad para Product: Angiographic catheter with hydrophilic surface. Model (s): Model: HNBR4.0-35-100-P-NS-KMP. Registro Anvisa n °: 10212990210. 2015-11-21 Brazil ANVISA
Alerta De Seguridad para Product: Angiographic catheter with hydrophilic surface. Model (s): HNBR5.0-35-90-P-NS-RUC. Anvisa Registration n ° 10212990210. 2015-11-21 Brazil ANVISA
Alerta De Seguridad para SOMATOM DEFINITION AS - Model 128-SLICES; 20-SLICES; 40-SLICES; 64-SLICES - Registration Number: 10345161981, Serial Number 66488 2015-11-20 Brazil ANVISA
Alerta De Seguridad para SOLIDOR HYGODERY NEEDLE, Hazard Class II, Model: 30 x0.8, Registration: 10237580042. Lot: BE30G / 14D01. 2015-09-23 Brazil ANVISA
Alerta De Seguridad para X-ray System - 9800 Plus, GE Healthcare, registration 80071260009, model 9800 PLUS, hazard class III, all equipment 2015-11-24 Brazil ANVISA
Alerta De Seguridad para OPTIMA CARDIOVASCULAR IMAGIOLOGY SYSTEM, models CL323 and IGS320, risk class III, registration 80071260314. Serial number: see attached chart. 2015-11-23 Brazil ANVISA
Alerta De Seguridad para ADVIA Centaur HIV Ag / Ab Combo Assay (CHIV), registration 10345161863, risk class IV, Lots: 73544070; 75980070; 76675070; 78024070; 79139070. 2015-11-26 Brazil ANVISA
Alerta De Seguridad para HIV Test Bioeasy, Registration No. 10071770701, Lot 03AD15001-A 2015-12-01 Brazil ANVISA
Alerta De Seguridad para CLINICAL CHEMISTRY SYSTEM DIMENSION RXL MAX - Registration nº 10345161632. Serial Numbers: Annex I - Distribution Map 2015-12-01 Brazil ANVISA