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  • Dispositivo 2073
  • Fabricante 2073
  • Evento 2209
  • Implante 0
Nombre Fecha Fecha de inicio País Fuente
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
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 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 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 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 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 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: 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 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: 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: 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: 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 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 Commercial Name: Optima Magnetic Resonance Imaging System. Technical Name: Magnetic Resonance Equipment. ANVISA registration number: 80071260300. Risk Class: II. Model affected: OPTIMA MR450w GEM. Serial numbers affected: 00000014131M67; 00000018480M64; 00000021158M61. All "MR Surgical Suite" tables that use mobile patient transfer plate between the GE table (model M0074SS) and the Surgical Magnus Maquet table with 1150 or 1180 table tops. 2018-05-23 Brazil ANVISA
Alerta De Seguridad para Trade Name: Urisys 1100. Technical Name: Instrument for urinalysis. ANVISA Registration Number: 10287410738. Hazard Class: I. Model Affected: N / A. Serial numbers affected: Destruction: UX09612510; UX09628084; UX09631442. Active: UX09656469. Stock: 9629877; UX09627628; 9629878; UX09642188. 2018-05-09 Brazil ANVISA
Alerta De Seguridad para Trade Name: HbA1c KIT. Technical Name: Glycosylated hemoglobin. ANVISA registration number: 80115310145. Risk Class: II. Model affected: R1: 2x15mL + R2: 1x10mL + R3: 1x5mL. Serial numbers affected: 1084091744, 1084091745, 1084091846 2018-05-09 Brazil ANVISA
Alerta De Seguridad para Commercial Name: X-ray Apparatus. Technical Name: Fixed X-ray Apparatus. ANVISA registration number: 10216710166. Risk Class: III. Model Affected: OmniDiagnost Elevates. Serial numbers affected: 317 2018-05-09 Brazil ANVISA
Alerta De Seguridad para Trade Name: SCITECH CATCH TIE. Technical Name: Filters. ANVISA registration number: 10413960200. Risk Class: II. Model affected: NA. Serial numbers affected: 111624 - LACO SNARE SCITECH 4FR 05MM X 120CM KIT. 112000 - LACO SNARE SCITECH 5FR 15MM X 120CM KIT. Lots: 023843, 024004, 024494, 024498, 024895 and 025282 2018-05-09 Brazil ANVISA
Alerta De Seguridad para Trade name: Aesculap single use bipolar instrument. Technical name: Aesculap single use bipolar instrument. ANVISA registration number: 80136990832. Risk class: III. Model affected: Caiman 5 mm. Affected Batches / Series Numbers: See Attachment "List of Batches Under Risk" 2018-05-07 Brazil ANVISA
Alerta De Seguridad para Commercial Name: BD Vacutainer Plastic Tube with Reagent for Vacuum Blood Collection. Technical name: Vacuum blood collection tube. Registration number ANVISA: 10033430470. Hazard class: I. Model affected: TUBE VACUTAINER CITRATE (9NC) 0,109M TAMPA HEMOGARD 2,7mL. Affected serial numbers: Lots #: 7180812, 7180813, 7180814, 7214941, 7214943, 7305988, 7346905, 7346912 and 8011842. 2018-05-07 Brazil ANVISA
Alerta De Seguridad para Trade name: Askina Calgitrol Paste 15 gr and Askina Gel 15 gr. Technical name: Askina Calgitrol Paste 15 gr and Askina Gel 15 gr. ANVISA registration number: 80136990789. Risk class: III. Affected template: 6241505, 001419SBR and 001419S. Affected serial numbers: Code 001419S: 514031, 514033 and 518472 ;. Code 001419SBR: 485431, 504281, 485431 and 504281 ;. Code 6241505: P2408, P2460, P2469, P2481, P2524, P2528, P2549, P2552, P2556 and P2577. " 2018-05-07 Brazil ANVISA
Alerta De Seguridad para Trade name: SURGICAL INSTRUMENTS. Technical Name: INSTRUMENTAL NON-ARTICULATED NON-CUTTING. ANVISA registration number: 80145901733. Risk class: I - LOW RISK. Affected Model: Pin Pullers and Screws. Serial numbers affected: "Cod .: 03.401.072 || Lot 10-2637 .. Cod .: 03.401.077 || Lot 10-4566." 2018-05-07 Brazil ANVISA
Alerta De Seguridad para Trade name: Elecsys Vitamin D total II. Technical name: Vitamin D. ANVISA registration number: 10287411273. Class of risk: II. Model Affected: N / A. Elecsys Vitamin D total II (100 tests) (Code: 7464215190 and Record: 10287411273) lots under risk in Brazil: 27398201/29822801 / 27398202. Elecsys Vitamin D total II (300 tests) (Code: 7028148190 and Registry: 10287411242) lots under risk in Brazil: 23010601/27396201 2018-05-04 Brazil ANVISA
Alerta De Seguridad para Trade name: Ultrasound System (ANVISA Registration 80035360066); LOGIQ 9 (ANVISA Registry 80035360066); LOGIQ E9 (ANVISA registration 80071260213); Vivid 7 (ANVISA registry 80071260187); Vivid E9 (ANVISA registration 80071260207); Vivid E80, Vivid E90 and Vivid E95 (ANVISA registration 80071260361). Technical Name: Ultrasound System. ANVISA registration number: 80035360066; 80071260213; 80071260187; 80071260207; 80071260361 .. Class of risk: II. Affected model: Logiq 9. Affected batches / series numbers: equipment installed since April 2015 or have been replaced with power cable since April 2015. 2018-05-04 Brazil ANVISA
Alerta De Seguridad para Trade name: Spectra Optia Apheresis System. Technical Name: Apheresis System. ANVISA registration number: 80554210002. Class of risk: III. Model affected: -. Batched / affected series numbers: All devices. 2018-05-04 Brazil ANVISA
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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.