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Nombre Fecha Fecha de inicio País Fuente
Alerta De Seguridad para Trade name: Linear Accelerator Elekta. Technical Name: Linear Accelerator. ANVISA registration number: 80569320007. Risk class: III. Affected Model: Integrity ™. Serial numbers affected :. INTEGRITY SOFTWARE / 16966-001 / 3.2.0 ;. INTEGRITY SOFTWARE / 30000301-001 / 3.2.0. INTEGRITY SOFTWARE / 20391-001 / 3.2.0. INTEGRITY SOFTWARE / 30000515-002 / 3.2.0. INTEGRITY SOFTWARE / 30000683-001 / 3.2.0 2018-01-18 Brazil ANVISA
Alerta De Seguridad para Name: Anesthesia System Carestation. Technical Name: Anesthesia Device. ANVISA registration number: 80071260222. Class of risk: III. Model affected: All. Serial numbers affected: 9100c (ANVISA Register 80071260222) 2018-01-23 Brazil ANVISA
Alerta De Seguridad para Trade name: - BD Phoenix Gram Negative; BD Phoenix Gram Negative Panels. Technical Name: Microorganism Identification / Antibiogram Device. ANVISA registration number: 10033430636; 10033430734. Class of risk: II. Affected Model: BD Phoenix NMIC - 203; BD Phoenix NMIC / ID-94; BD Phoenix. Serial numbers affected: PX2049; PX2078; PX2120; PX2098; PX2063; PX2079; PX2097; PX2099; PX2121; PX2134 2018-01-26 Brazil ANVISA
Alerta De Seguridad para Trade name: VITEK 2 AST family. Technical name: Identification device / antibiogram of microorganisms. ANVISA registration number: 10158120592. Class of risk: II. Affected model: VITEK 2 AST P585 and VITEK 2 AST P612. Affected serial numbers: Field action is not dependent batch. 2018-01-16 Brazil ANVISA
Notificaciones De Seguridad De Campo acerca de architect testosterone test 2013-01-17 Poland ORMPMDBP
Alerta De Seguridad para Trade name: Lubrigel Intimate Lubricant. Technical Name: Intimate Lubricant. ANVISA registration number: 80005910023. Class of risk: II. Model affected: Sache 5g. Serial numbers affected: 17/0575; 17/0577; 17/0584; 17/0585; 17/0601; 17/0602; 17/0638; 17/0739; 17/0740; 17/0751; 17/0752; 17/0753; 17/0754; 17/0768; 17/0769; 17/0770; 17/0771; 17/0799; 17/0800; 17/0801; 17/0802 and 17/0803. 2018-01-11 Brazil ANVISA
Alerta De Seguridad para Trade name: i-STAT KAOLIN ACT CARTRIDGE. Technical Name: Activated Coagulation Time. ANVISA registration number: 80146501500. Risk class: III. Affected Model: Not applicable. Serial Numbers Affected: R16354A; R17025; R17041; R17080; R17110; R17123; R17165; R17197; R17201A; R17197A; R17273; R15310; R15356; R16034; R16067; R16115; R16146; R16174; R16222; R16254; R16278; R16304; R16316; R17007; R17038; R17059; R17128; R17201; R17250; R17276; R17321 2018-01-23 Brazil ANVISA
Alerta De Seguridad para Trade name: Surgical Focus Vol. Technical Name: Surgical Focus. ANVISA Registration Number: 80259110132. Hazard Class: I. Model Affected: Surgical Focus Volista Access .. Serial Numbers Affected: 36008; 38005; 38033; 38039; 500153; 35000; 36016; 38008; 38013; 38032; 38034; 38037; 500000; 500001; 500001; 500002; 500002; 500003; 500004; 500005; 500006; 500007; 500008; 500009; 500010; 500011; 500012; 500013; 500014; 500015; 500016; 1002; 36031; 36032; 36033; 36034; 36035; 36036; 36037; 36038; 36039; 36040; 38006; 38011; 38030; 38035; 38038; 38058; 38059; 38060; 38061; 38063; 38064; 38029; 38033; 38036; 500133; 36017; 36018; 38035; 38007; 38010; 38033; 38034; 500155; 31000; 38009; 38012; 38031; 38035; 38038; 20509; 500154 2018-01-28 Brazil ANVISA
Alerta De Seguridad para Laboratory tests using biotin technology assay methodologies to promote binding with specific protein biomarkers. 2018-02-08 Brazil ANVISA
Alerta De Seguridad para Trade name: Qualitas Gama. Technical Name: Motorized Bed. ANVISA Registration Number: 80509610013. Hazard Class: I. Model Affected: PA-66254 * XS. Serial numbers affected: 9010157-00003; 9010157-00004; 9010157-00018; 9010157-00007; 9010157-00015; 9010157-00017; 9010157-00002; 9010157-00008; 9010157-00006; 9010157-00016; 9010157-00013; 9010157-00001; 9010157-00012; 9010157-00005; 9010157-00019; 9010157-00011; 9010088-00005; 9010088-00011; 9010088-00007; 9010088-00014; 9010088-00001; 9010088-00015; 9010088-00003; 9010088-00008; 9010088-00009; 9010088-00006; 9010088-00002; 9010088-00010; 9010088-00012; 9010088-00004. 2018-02-22 Brazil ANVISA
Alerta De Seguridad para Technical Name: Angiography Equipment. ANVISA registration number: 10345162020. Risk class: III. Affected Model: Artis One. Serial Number Affected: 82190; 82235; 82176; 82062; 82032; 82197; 82187; 82046; 82030; 82136; 82200; 82063; 82090; 82092; 82170; 82216; 82048; 82110; 82143; 82084; 82058; 82067; 82161 2018-02-22 Brazil ANVISA
Alerta De Seguridad para Note (03/28/2018): Based on the 006/2018 / SCVSAT notification from the State Health Department of Paraná, the information on affected lots was rectified and this field action applies to the following lots: . Commercial Name: Protective Cover Bed; ANVISA registration number: 80670160004; Risk class: I; Affected Model: Protective Cover Camouflage Breathalyzer with Ring; Lot: 1702006, 1708033, 1709011 ... Commercial Name: Protective Cover Bed; ANVISA registration number: 80670160004; Risk class: I; Affected Model: Protective Cloak Breathable Videolaparoscopy Cover; Lot: 1709002 ... Commercial Name: Protective Cover Bed; ANVISA registration number: 80670160004; Risk class: I; Affected Model: Ultrasonic Tweezer Protective Cover; Lot: 1709003 ... Trade name: Artrolon Standard; ANVISA registration number: 80670160045; Risk class: II; Model Affected: Artrolon Standard 4V; Lot: 1702007 ... Trade Name: Auxiliary Table Field Bed; ANVISA registration number: 80670160001; Risk class: I; Model Affected: Auxiliary Table Field Bed 90x120cm; Lot: 1702010, 1702011, 1709001, 1709007 ... Trade name: Blue Field in TNT for Auxiliary Table Bed; ANVISA registration number: 80670160006; Risk class: I; Affected Model: Blue Field in TNT for Auxiliary Table Unclosed Bed 130x180cm; Lot: 1702012. 2018-02-22 Brazil ANVISA
Alerta De Seguridad para Trade name: Uphold Vaginal Support. Technical Name: Screens. ANVISA registration number: 10341350701. Class of risk: III. Model Affected: M0068317080. Capio Suture Capture Device. Technical Name: Suture Gripper. ANVISA registration number: 10341350717. Class of risk: II. Model Affected: M0068311251. Capio ™ SLIM - Suture Capture Device. Technical Name: Suture Gripper. ANVISA registration number: 10341350777. Risk class: II. Model Affected: M0068318250. Uphold Lite with Capio SLIM - Vaginal Support System. Technical Name: Screen. ANVISA registration number: 10341350779. Risk class: III. Affected Model: M0068318170 2018-02-22 Brazil ANVISA
Alerta De Seguridad para Commercial Name: Patient Ceiling Elevators. Technical Name: Movement / Patient Transfer Device. ANVISA Registration Number: 80259110133. Hazard Class: I. Model Affected: Maxi Sky 2. Serial Number Affected: 300174590 2018-02-23 Brazil ANVISA
Alerta De Seguridad para Trade name: Atrial catheter. Technical Name: Catheters. ANVISA registration number: 10166360031. Risk class: IV. Model affected: AC, AE, AH. Serial number affected :. Code AC: lot 06 series 01 to 10, lot 07 series 01 to 10. Code AE: lots 17 to 29 series 01 to 10. Code AH: lot 04 series 01 to 10 2018-02-23 Brazil ANVISA
Alerta De Seguridad para Commercial Name: Ultrasound System. Technical Name: Ultrasound Device. ANVISA registration number: 80372200002. Hazard class: II. Model affected: MyLab70 XVG; MyLab60; MyLab70 X Vision. Serial numbers affected: 4263; 4798; 5198; 5205; 5321; 5379; 5476; 5880; 5880; 5923; 6412 2018-02-23 Brazil ANVISA
Alerta De Seguridad para Trade name: Centricity Pacs IW. Technical Name: Software. ANVISA registration number: 80071260309. Risk class: II. Affected Model: Centricity Pacs IW With Universal Viewer | Centricity Universal Viewer. Serial Number Affected: Centricity Pacs IW With Universal Viewer | Centricity Universal Viewer (80071260309) 2018-02-20 Brazil ANVISA
Alerta De Seguridad para Trade name: ADVIA Centaur Cyclosporin (CsA); ADVIA Centaur DHEA-SO4 (DHEAS); ADVIA CENTAUR FOL; ADVIA CENTAUR HBc IgM-. Technical Name: Ciclosporin; Dehydroepiandrosterone Sulfate (Dhea-S); Folate. Nuclear Immunoglobulin M for Hepatitis B Virus. ANVISA registration number: 10345161772; 10345161738; 10345160571; 10345160594. Class of risk: III; II; II; IV. Model Affected: N / A. Serial number affected: See distribution map 2018-02-23 Brazil ANVISA
Alerta De Seguridad para Commercial Name: Ultrasound System. Technical Name: Ultrasound Device. ANVISA registration number: 80372200002. Hazard class: II. Model affected: MyLab70 XVG; MyLab60; MyLab70 X Vision. Serial numbers affected: 1093; 1096; 1103; 1106; 1135; 1171; 1189; 1191; 1193; 1209; 1212; 1223; 1224; 1225; 1251; 1254; 1255; 1258; 1259; 1260; 1263; 1264; 1265; 1266; 1267; 1268; 1271; 1274; 1275; 1276; 1353; 1436; 1437; 1442; 1443; 1463; 1466; 1471; 1472; 1493; 1498; 1499; 1506; 1520; 1521; 1522; 1523; 1524; 1528; 1529; 153/01370; 153/01373; 153/01383; 1531; 1532; 1533; 1537; 1538; 1544; 1545; 1546; 1547; 1548; 1621; 1622; 1630; 1631; 1632; 1801; 1802; 1803; 1804; 1805; 1837; 1838; 1839; 1870; 1871; 1872; 2075; 2077; 2137; 2138; 2147; 860; 984; 985; 988; 991; 1341; 1512; 1582; 1588; 1604; 1605; 1757; 1783; 1791; 1824; 1830; 1985; 2096 2018-02-27 Brazil ANVISA