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Name Date Date initiated Country Source
Safety Alert for Trade Name: Endokit /// Record Number: 80689090090 /// Hazard Class: III (High Risk) /// Models Affected: REK24N / REK26N /// Lots Affected: NGYIX401; NGYIX402; NGZG1732 2016-09-12 Brazil ANVISA
Safety Alert for Technical Name: Stryker /// ANVISA Registration Number: 80005430152 /// Risk Class: III - High Risk /// Serial Numbers Affected Product name: PROT CLEAR HEAD V40 LFIT 36MM / 5 /// Technical name: : See Distribution Map 2016-10-03 Brazil ANVISA
Safety Alert for Trade name: TRIDENTE CERÂMICA /// Technical name: QUADRIL ARTHROPLASTIC SYSTEM /// ANVISA registration number: 80005430060 /// Risk class: III - High risk /// Model: ACETABULO LEVER /// Serial numbers affected: See Distribution map 2016-10-03 Brazil ANVISA
Safety Alert for Trade Name: Lysercell Technical Name: Lysing Solution For Hematology ANVISA Registration Number: 80015490091 Hazard Class: I Affected Model: Lysercell WDF Affected Lot: P5002. 2016-08-12 Brazil ANVISA
Safety Alert for BARD HICKMAN / LEONARD / BROVIAC / / Technical name: Catheters /// ANVISA registration number: 10178010080 /// Hazard class: IV - Maximum risk /// Model: Hickman 9Fr /// Affected serial numbers: HUZB0322 and HUZB1750. 2016-09-14 Brazil ANVISA
Safety Alert for Trade name: INSTRUMENTAL FOR STRYKER KNEE ARTROPLASTY /// Technical name: Surgical instruments /// ANVISA registration number: 80005430207 Hazard class: I - Low Risk Model affected: CLAMP PATELAR Serial numbers affected: See Distribution map 2016-08-11 Brazil ANVISA
Safety Alert for Categorization of notifications in Technovigilance. 2016-10-18 Brazil ANVISA
Safety Alert for E-test colistin (30 and 100 strips) ANVISA registration number: 10158120623 Hazard class: II Affected model: n / a Serial numbers affected: - Reference number 537300: 100483220 , 1004437930,1004329220,1004190730,1004171220,1003969990,1003767080,1003725600,1003610660,1003532330,1003514810, 1003409250,1003297790,1002849110,1002816570,1002780680,1002594030,1002517610,1002438560,1002336190,1002154530,1001742150,1001496200,1001417080 1001260560.1001158900, 1000941970,1000893880,1000756330 and 1000714690. - Reference 537308: 10044750,1002523000,1002703940,1002795210,1002889130,1002989530,1003456440,1003456440 1003616140,1003767090,1004177660,1004596710,1004752310 and 1002343060 2016-08-10 Brazil ANVISA
Safety Alert for Two products are affected by the action of Field: 1. Trade Name: E.CAM SIGNATURE SERIES MARK SIEMENS - Technical Name: Camile Cintilografica (Gamma Camera) - Registration 10234230040 - Model: E.CAM Signature Series, brand SIEMENS /// 2. Trade name: SISTEMA SPECT - Registro 10345161991 - Model: Symbia E - Technical name: Nuclear Imaging System - ANVISA registration number: 80004040126 /// Number of series affected: 3002; 3003; 3006; 4004; 1086; 1093; 1126; 1007; 2016; 3051; 3072; 4019; 4022; 4091; 4102; 4124; 4192; 5017; 5028; 4042; 4091; 7546; 7552; 8671; 8797; 8019; 5626; 7016; 7006; 7507; 550; 588; 3097; 11194; 11463; 10012; 11048; 11073; 9002; 9036; 9029; 1031; ; 1033; 1040; 1047; 1051; 1056; 1066; 1084; 1085; 1050; 1111; 1113; 1115; 1161; 1169; 1241; 1267; 1334; 1358; 1366; 1367; 1368; 1371; 1372; 1157; 1166; 1173; 1194; 1210; 1231; 1259; ; 1267; 1303; 1314; 1318; 1355; 1383; 1391; 1403; 1404; 1406; 1678; 1681; 1682; 1032. 2016-10-25 Brazil ANVISA
Safety Alert for Two products are affected by the field action. 1. Trade name: RUBELLA IGM IMMULITE / IMMULITE 1000 - Technical name: Rubella virus - Register 10345160740 - Affected lot (s): 333 and 334. ///. 2. Trade name: RUBEOLA IgM IMMULITE 2000 - Registration 10345160813 - Affected lots: 237, 236M, 238, 239 ///. Risk Class: III - Products that present a high risk to the user, the patient and / or the public health 2016-10-25 Brazil ANVISA
Safety Alert for The Field Action affects five products registered in Brazil. FORTIFY ™ - Registration 10332340305. UNIFY - Registration 10332340299. Fortify Assura VR - Registration 10332340358. Unify Assura - Registration 10332340344. Implantable Cardioverter and Defibrillator Quadra Assura - Record 10332340343 2016-10-24 Brazil ANVISA
Safety Alert for Trade name: ALDOLASE RANDOX. Technical Name: ALDOLASE. ANVISA registration number: 80158990141. Risk class: I - Low Risk. Model Affected: AD189. Batch / serial numbers affected: 370813; 365747; 347842; 347842; 339868; 339868; 330802; 322815 2016-10-31 Brazil ANVISA
Safety Alert for Five products affected by the Field Action. 1. PIPELINE EMBOLIZING DEVICE - Registration 10349000471 - Technical Name: ANEURISMA IMPLANT - Risk Class IV ;. 2. ALLIGATOR RECOVERY DEVICE - Registration 10349000457 - Technical Name: DEVICES - Risk Class IV ;. 3. HYDROFILIC GUIDE X-CELERATOR - Registration 10349000313 - Technical Name: FIO CARDIOVASCULAR GUIDE - Risk Class II ;. 4. ULTRAFLOW HPC FLOW ORIENTED MICROCATETER - Record 10349000461 - Technical Name: INTRAVASCULAR MICROPHYDRUS CATETER - Risk Class IV ;. 5. MARATHON MICRO CATHETER FLOW DIRECTED - Record 10349000478 - Technical Name: INTRAVASCULAR MICROPHEPER CATHETER - Risk Class IV ;. Affected lots: Products manufactured between August 2014 and September 2016 2016-10-05 Brazil ANVISA
Safety Alert for Trade name: Kit Nat HIV / HCV / HBV Bio-Manguinhos ///. Technical Name: HIV VIRUS NUCLEIC ACID, HBV AND HCV ///. ANVISA registration number: 80142170025 ///. Risk class: IV - High Risk ///. Number of batches affected: 14ONT040Z; 14ONT042Z; 152NB009Z; 155NB031Z; 155NB033Z 2016-10-27 Brazil ANVISA
Safety Alert for Trade name: Vital Signs Monitor DX2022 + ///. Technical Name: Vital Signs Monitor ///. ANVISA registration number: 10293490043 ///. Risk class: III - High Risk ///. Model affected: DX2022 + ///. Serial numbers affected: From 143300004 through 163302565 2016-10-14 Brazil ANVISA
Safety Alert for Trade name: Zelos PTA Balloon Catheter ///. Technical name: Dilating balloons ///. ANVISA registration number: 80134860129 ///. Risk class: III - High Risk ///. Affected Model: 1740-1202, 1740-1204, 1740-1402, 1740-1404, 1740-1602, 1740-1604, 1740-1802, 1740-1804, 1740-2002, 1740-2004, 1740-2202, 1740-2204 , 1740-2402, 1740-2404, 1740-2602, 1740-2604, 1740-2802, 1740-2804. Affected lots: 6000120532; 6000125088; 6000114594; 6000135485; 6000132932; 6000125362; 6000118615; 6000134870; 6000126658; 6000120181; 6000134871; 6000122178; 6000135767; 6000133004; 6000125184; 6000118560; 6000133399; 6000131825; 6000122178; 6000114594; 6000126135; 6000116861; 6000114097; 6000126155; 6000120181; 6000122609; 6000124187; 6000117794; 6000108952; 6000114594; 6000126135; 6000116861; 6000131502; 6000120181; 6000122178; 6000124187; 6000108952; 6000117822; 6000108953; 6000118560; 6000126135; 6000132020; 6000131502; 6000128186; 60000126135; 60000121977; 60000126044; 60000108952; 6000086400 6000123357; 6000132020; 6000101035; 6000121977; 6000123182; 6000123182; 6000122750; 6000117794; 6000114097; 6000112476; 6000123732; 6000104902; 6000116861; 6000112476; 6000108952; 6000122608; 6000123357; 6000124187; 6000126155 2016-09-06 Brazil ANVISA
Safety Alert for Trade name: iPlan Surgical / Clinical Planning Software, brand Brainlab ///. Technical name: Surgical / Clinical Planning Software ///. ANVISA registration number: 80042070008 ///. Risk class: III - High Risk 2016-10-07 Brazil ANVISA
Safety Alert for Trade name: ANCORA DE REINSERÇÃO CQR. Technical Name: Implant for Ligament. ANVISA registration number: 80519830007. Risk class: III - High Risk. Model affected: I.6 MM 2016-10-25 Brazil ANVISA
Safety Alert for Allura Xper Angiography Equipment Technical Name: Angiography Equipment ANVISA Registration Number: 10216710153 Hazard Class: III - High Risk Affected Models: ALLURA XPER FD10 OR table; ALLURA XPER FD20 OR table; ALLURA XPER FD10 (ground); ALLURA XPER FD10 (ceiling); ALLURA XPER FD20 (ground); ALLURA XPER FD20 (ceiling) Series Affected: 45, 53, 139, 170, 180, 123, 263, 173, 174, 195, 179. 2016-09-23 Brazil ANVISA
Safety Alert for Product name: VITEK AST N 239 Card - Colistin (cs01n) Technical Name: VITEK AST Card N 239 ANVISA Registration Number: 10158120592 Hazard Class: II Model Affected: Not Applicable 2017-05-24 Brazil ANVISA
Safety Alert for Product Category: Angiography Equipment Allura Xper. Technical Name: Angiography Equipment. ANVISA registration number: 10216710153. Class of risk: III - High Risk. Models Affected: ALLURA XPER FD10 OR table; ALLURA XPER FD20 OR table; ALLURA XPER FD10 (ground); ALLURA XPER FD10 (ceiling); ALLURA XPER FD20 (ground); ALLURA XPER FD20 (ceiling). Series Affected: See below 2016-09-23 Brazil ANVISA
Safety Alert for Commercial Name: CT Scanning System / Ingenuity CT. Technical name: CT Scanner / Computerized Tomography Scanner. ANVISA registration number: 10216710191. Class of risk: III - High Risk. Affected Models: Brilliance CT 6-Slice / Brilliance CT 64-Slice / Brilliance iCT / Brilliance iCT / Brilliance iCT / Brilliance CT 16-Slice / Ingenuity CT / Ingenuity Flex. Series Affected: See below 2016-09-13 Brazil ANVISA
Safety Alert for Commercial Name: ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. ANVISA Registration Number: 80146501834 .. Hazard Class: III. Lots: attached list .. Lot lot affected: 2.555 units .. Number of units distributed: 1.980. 2016-07-04 Brazil ANVISA
Safety Alert for Trade name: ACCELERATOR - Accelerator 3600. ANVISA registration number: 80146501830. Hazard class: I. Lots - does not apply. Batch Affected Quantity: 2 2016-06-13 Brazil ANVISA
Field Safety Notices about alinity work module and processing module 2017-10-24 Poland ORMPMDBP