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Nombre Fecha Fecha de inicio País Fuente
Alerta De Seguridad para ENGEN LABORATORY AUTOMATION SYSTEM ENGEN LABORATORY AUTOMATION SYSTEM ANVISA Registration Number: 80145901089 Hazard Class: I Affected Model: ENGEN LABORATORY AUTOMATION SYSTEM Affected Batch / Serial Numbers: Series - Engen 2017-04-11 Brazil ANVISA
Alerta De Seguridad para VITROS NT-PRO BNP REAGENT KIT Technical Name: HUMAN BRAIN NATURAL URBRID PEPTIDE (BNP) ANVISA Registration Number: 80145900933 Hazard Class: II Affected Model: Kit consisting of: 100 coated wells; 8.2 ml of conjugated reagent; 8.2 ml of biotinylated antibody reagent. Affected batch / serial numbers: SKU 6802156, lot 1570, 1580 2017-04-11 Brazil ANVISA
Alerta De Seguridad para AXIOM ICONOS X-ray System Technical Name: X-Ray Fluoroscopic System ANVISA Registration Number: 10234230063 Hazard Class: III Affected Model: R100, R200 Serial Numbers Affected: 4603, 10021, 10024, 10025, 10026, 10034, 10039, 10039, 10019, 10243, 10244, 11000, 11003, 11018, 11101, 11113, 12005, 12018, 12111, 12132, 12133, 12192, 12194, 12123, 12223, 12401, 12403, 12405, 12406 2017-04-20 Brazil ANVISA
Alerta De Seguridad para Implanted Infusion Pump Medtronic Technical Name: Synchromed II 8637-20 / Synchromed II 8637-40 ANVISA Registration Number: 10339190229 Hazard Class: IV Affected Model: 8637-20 and 8637-40 Serial Numbers Affected: PUMP 8637 -20 SM2 20ML EMAN US JUN BATRY; PUMP 8637-20 SM2 20ML PAP MAN US JUN BAT; PUMP 8637-20 SM2 20ML PAPER MAN USMKT SL; PUMP 8637-20 SM2 20ML PAPR MAN USMKTJUNC PUMP 8637-20 SYNCH II 20ML US MKT SL; PUMP 8637-20 SYNCHMED II 20ML PF; PUMP 8637-20 SYNCHMED II PCKT FILL L105; PUMP 8637-20 SYNCHROMED II L089; PUMP 8637-20 SYNCHROMED II OUS L105; PUMP 8637-40 SYNCHMED II PCKT FILL L105; PUMP 8637-40 SYNCHROMED II L089; PUMP 8637-40 SYNCHROMED II OUS L105. 2017-04-12 Brazil ANVISA
Alerta De Seguridad para Trade name: Broca Esf. Diam. Hi-Line Great. Thick IT / Drill Esf. Diam. Hi-Line Great. Thick Tip Technical Name: Broca Esf. Diam. Hi-Line Great. Thick IT / Drill Esf. Diam. Hi-Line Great. Affected serial numbers: 51745118, 51649830, 51708484, 51838047, 51634741 and 51293170. Note: The unit of lot 51293170 was used during the disclosure project. of the product in 2005, and is not distributed to the customer. 2017-04-12 Brazil ANVISA
Alerta De Seguridad para Product name: Disposable Stylus Technical Name: Biscuit ANVISA Registration Number: 10229650002 Hazard Class: II Model Affected: Number 11 Serial Numbers Affected: Lot: EEC2756 2017-04-12 Brazil ANVISA
Alerta De Seguridad para ADVIA Centaur BR Technical Name: ANTIGEN CA ANVISA Registration Number: 10345161849 Hazard Class: III Affected Model: 250 Test Kit / 50 Test Kit 2017-04-13 Brazil ANVISA
Alerta De Seguridad para Name of INTRAFIX PRIMELINE AIR IL Technical Name: Family of Gravitational Infusion Equipment for Parental Solutions and Medications ANVISA Registration Number: 80136990540 Hazard Class: II Model Affected: 401450P Serial Numbers Affected: 17A20LB026 2017-04-13 Brazil ANVISA
Alerta De Seguridad para Trade name: Family of differentials for identification of microorganisms - Vitek 2 Identification Technical name: Vitek 2 cards Identification Registration number ANVISA: 10158120571 Hazard class: II 2017-04-25 Brazil ANVISA
Alerta De Seguridad para Schaerer® Surgical table Schaerer® Surgical table Surgical table Surgical table Surgical table Surgical table Schaerer® arcus 501 Schaerer® arcus 601 Surgical table Schaerer® arcus 701 Surgical table : AR-4815, AR-4816, AR-4817, AR-4818, AR-4819, AR-4820, AR-4829, AR-4842. 2017-04-19 Brazil ANVISA
Alerta De Seguridad para Trade name: Comp. Femoral Cementate Technical Name: Implantable Material ANVISA Registration Number: 10417940046 Hazard Class: III Model Affected: Femoral Modular III Component Right Affected Series Numbers: 00219S and 00202S 2017-04-19 Brazil ANVISA
Alerta De Seguridad para BD Vacutainer Glass Tubes with Vacuum Blood Collection Reagents Technical Name: BOTTLE OR MATERIAL FOR COLLECTION, STORAGE OR TRANSPORTATION OF BIOLOGICAL SAMPLES ANVISA Registration Number: 10033430467 Hazard Class: I Affected Model: VACUTAINER TUBE CITRATE .105 M TAMPA HEMOGARD 4.5 ML Serial numbers affected: Lots: 5336909; 5357632; 6,040,953; 6064634; 6124932; 6173983; 6187600 2017-04-19 Brazil ANVISA
Alerta De Seguridad para Technical Name: Non-absorbable tubular angled plate for osteosynthesis ANVISA Registration Number: 80034760050 Hazard Class: III Model Affected: 2266-318-095 Serial Numbers Affected: 00107967/006939 - 08 units - Date of manufacture: 01/14/2016 00109330/006939 - 08 units - Date of manufacture: 01/14/2016 00107963/006939 - 11 units - Date of manufacture: 01/14/2016 00110188/006939 - 11 units - Date of manufacture: 01/14/2016 00107966/006939 - 04 units - Date of manufacture: 01/14/2016 2017-04-19 Brazil ANVISA
Alerta De Seguridad para Model affected: Monaco Serial numbers affected: Monaco 5.10.2, 5.11.0, 5.11,1 2017-01-31 Brazil ANVISA
Alerta De Seguridad para Product name: Dimension EXL TNI Flex Technical name: TROPONIN Registration number ANVISA: 10345161707 Hazard class: III Model affected: 144 tests (4x36) Serial numbers affected: All lots 2017-04-25 Brazil ANVISA
Alerta De Seguridad para Allura Xper Angiography Equipment Angiography Equipment Angiography Equipment ANVISA Registration Number: 10216710153 Hazard Class: III Model Affected: Allura Xper FD10 Ceiling / Allura Xper FD10 Ceiling / Allura Xper FD20 Ceiling / Allura Xper FD20 Floor / Allura Xper FD10 OR Table / Allura Xper FD20 OR Table Serial numbers affected: 1330; 1308. 2017-04-25 Brazil ANVISA
Alerta De Seguridad para Product Name: ACUSON Diagnostic Ultrasound System Technical Name: Ultrasound Apparatus ANVISA Registration Number: 10345162017 Hazard Class: II Model Affected: ACUSON S2000 Serial Numbers Affected: 211771; 211784; 213087; 213596; 213886; 213936; 214179; 214493 2017-04-27 Brazil ANVISA
Alerta De Seguridad para Trade name: CAL IRI CALIBRATOR ADVIA CENTAUR ACS 180 SYSTEMS; ADVIA CENTAUR IRI Technical name: CAL IRI CALIBRATOR ADVIA CENTAUR ACS 180 SYSTEMS; ADVIA CENTAUR IRI ANVISA registration number: 10345160303; 10345161868 Affected Model: MAMMOMAT Inspiration 2017-04-28 Brazil ANVISA
Alerta De Seguridad para Trade name: Steam Sterilizers GSS67F. Technical Name: Autoclave. ANVISA registration number: 80259110142. Hazard class: II. Model Affected: GSS6710; GSS6713. Lots of numbers affected: 0011218904-010-01; 0011218904-060-01; 0011207210-010-02; 0011207210-060-01; 0011207210-010-01; 0011220774-010-01; BAA083638; BAA083636; BAA083637; BAA083635 2018-04-06 Brazil ANVISA
Alerta De Seguridad para Mammography Device: Mammography Device: Mammography Device: Mammography Device: Mammography Device: Mammography Device: Mammography Device: Mammography Device: Mammography Device: ANVISA Registration Number: 10345162027 Class Affected: MAMMOMAT Inspiration Serial numbers affected: 3063, 3400, 3630, 3639, 3746, 3828, 4169, 4275, 4276, 4451, 4704, 4708, 4710, 5047, 5078, 6044, 6204, 6488 2017-04-27 Brazil ANVISA
Alerta De Seguridad para Trade name: LATEX GLOVE FOR NON-SURGICAL PROCEDURE Technical name: LATEX GLOVE FOR NON-SURGICAL PROCEDURE Registration number ANVISA: 80680560001 Risk class: I Affected model: NON-SURGICAL PROCEDURE GLOVE WITH SUPERLATEXX POWDER: PP; P; M; G. Series numbers affected: 12L2785M; 11L2786S; 11L2787S; 12L2787M; 12L2788XS; 11L2788S; 12L2788S; 12L2788M; 12L2788L. 2017-05-16 Brazil ANVISA
Alerta De Seguridad para Trade Name: Procedure Glove Proced Powder Free Technical Name: Procedure Glove ANVISA Registration Number: 80256170002 Hazard Class: I Affected Model: Procedure Sleeve Powder Free, non-sterile, smooth, ambidextrous, dust-free. Serial numbers affected: PPFA001G; PPFC011G; PPFF022G; PPFF038G; PPFC003H 2017-05-11 Brazil ANVISA
Alerta De Seguridad para Anesthesia System Anesthesia System Anesthesia System ANVISA Registration Number: 80071260356 Hazard Class: III Affected Model: Carestation 620, Carestation 650 and Carestation 650c Series numbers affected: Models Carestation 620, Carestation 650 and Carestation 650c with software version Revision.01 2017-05-11 Brazil ANVISA
Notificaciones De Seguridad De Campo acerca de massage beds ceragem-e 2012-02-20 Poland ORMPMDBP
Alerta De Seguridad para Technical Name: CENTRIFUGAL PUMP FOR CARDIOPULMONARY BY-PASS SYSTEM Registration Number: 80102511251 Hazard Class: III Model Affected: S5, C5 Serial Numbers Affected: NS 16S15049 and 16S15050 2017-05-15 Brazil ANVISA