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Nombre Fecha Fecha de inicio País Fuente
Alerta De Seguridad para DIAGNOSTIC ULTRASOUND SYSTEM, model ACUSON SC2000 -. registry 10345161999 - Class of risk II. Serial Numbers: 400758; 400762; 400831; 400723 and 401809. 2016-02-03 Brazil ANVISA
Alerta De Seguridad para Knee Arthroplasty System / Knee Prosthesis; models: 6307-00-006 / 6307-00-008 / 6307-00-009; registration 80199020013; risk class III; lots: 61988031; 62054615; 62041152; 6,180,029; 61806575; 62005748; 61815746; 62041157; 61822616; 62005756; 62054626; 62068198; 62128274; 61831823; 61831831; 61850057; 61824682. 2016-02-01 Brazil ANVISA
Alerta De Seguridad para Eurospine instruments, HRCID09 models - 3x9 thin lumbar distractor - Lot 883; HRCID10 - Fine lumbar distractor 3.5x10 - Lot 856; HRCID11 - Fine lumbar distractor 3.5x11 - Lot 883, record 10355870048, risk class I. 2016-02-01 Brazil ANVISA
Alerta De Seguridad para BLOOD COLLECTION BAG CPDA-1, Registration no. 10154450085 - lot: 71HL07AA00-04 2016-01-26 Brazil ANVISA
Notificaciones De Seguridad De Campo acerca de heartmate 3 system for left chamber, catalog no. 106524int - lvas hm3 set 2018-06-08 Poland ORMPMDBP
Alerta De Seguridad para Clip Delivery System - Mitraclip System, model CDS02ST, registration 80146501877, Risk class IV. The following lots are in stock at Abbott Vascular: 50930U101, 50930U102. 50930U103, 50930U104, 50930U105, 50930U106, 50930U107, 50930U108, 50930U110, 50930U111, 50930U112, 50930U113, 50930U115, 50930U116, 50930U117, 50930U118, 50930U119, 50930U126, 50930U132, 50930U129, 50930U128, 50930U131, 50930U130, 50930U127, 50930U133, 50930U134, 51118U106, 51118U113, 51118U119, 51118U128. 2016-02-04 Brazil ANVISA
Alerta De Seguridad para INSTRUMENTAL FOR STRINGS TS STRYKER TRAUMA, Wire Guide, register 80005430088, risk class I, lots / series: K076CCF; K0AF3C9; K0B8538; K07B727; K785079; K610172; K03FE02; K043C6B; K07EF49; K083C1D; K0DE2EC; K889978; K140480; K282163; K487845 and K261793 2016-02-05 Brazil ANVISA
Alerta De Seguridad para CATETER FOR BLOOD PRESSURE MONITORING. Model: C-PMS-300-RA; C-PMS-250; C-PMS-400-RA; C-PMS-400-FA; C-PMS-250-RA, registration 10212990205; risk class II. Lots / Series: 5810917; 5824548, 5824547; 5,810,905; NS6014457; NS6047399; NS6047398; NS6047397; NS6047396; NS6045805; NS6047442; NS6047440; NS6014456; 6067782; NS6063331; NS6063328; NS6108226 2016-02-12 Brazil ANVISA
Alerta De Seguridad para DUOLYS, IMUNOHEMATOLOGY - ABO - MONOCLONAL ORIGIN, record 10154450118, model: 12 DuoLys microplates for 12 x 8 ABO-RH1 typing and RH-K phenotypes (each microplate contains 8 wells of Anti-A, Anti-B, Anti-A, B , Anti-E, Anti-E, Anti-K, Negative Control and 2 x 8 empty wells) + 1 vial of 40 ml of MagneLys, hazard class IV, lots: PhenoLys for 12 x 16 RH-K phenotypes (each microplate contains 2 x 8 wells of negative control, 2 x 8 negative control wells, Anti-C, Anti-E, Anti-c, Anti-e, Anti-K) + 1 vial of 40 ml MagneLys, hazard class IV, batches: 618000, 619000, 620000. 2016-02-10 Brazil ANVISA
Alerta De Seguridad para BARD TRUGUIDE COAXIAL NEEDLE FOR BIOPSY, model C2016B, registration 80689090075, hazard class II, lots: REWL0924, REXA1695, REXB1529, REXC1632. 2016-02-12 Brazil ANVISA
Alerta De Seguridad para Three-dimensional Planning System for Eclipse Radiotherapy, model eclipse versions 11; 13.0; 13.5 and 13.6, registration 10405410007, risk class III, various series. 2016-02-04 Brazil ANVISA
Alerta De Seguridad para BAG FOR BLOOD COLLECTION CPDA-1, model: Triple bag with plasticizers DEHP and TOTM - Composampler, register 10154450085, class of risk III, lot: 71IG03AA00 2016-02-12 Brazil ANVISA
Alerta De Seguridad para VITAL GOLD SCALP DISPOSABLE WITH SAFETY DEVICE, size 19G, registration 10296900048, hazard class II, lot 140415. 2016-01-11 Brazil ANVISA
Alerta De Seguridad para Hemodialysis Machine, Dialog + and Dialog + HDF models online (7102005, 7102072, 710200C and 710207E), registration 80136990498, risk class III, various series (SEE ANNEX). 2016-02-15 Brazil ANVISA
Alerta De Seguridad para Trade name: Antiseptic Towels Technical Name: Assepsis Handkerchief in Medical Procedures ANVISA Registration Number: 10178010150 Hazard Class: I Affected Model: CODE 9602-X 2016-08-30 Brazil ANVISA
Alerta De Seguridad para Commercial Name: Lightspeed Computed Tomography System. ANVISA registration number: 80071260076. Risk class: III. Affected model (s); and Lot (s) / Serial number (s) affected :. 00000327271CN3 (São Paulo-SP). 00000346702CN4 (Goiânia-GO); 00000002103PT0 (Ribeirão Preto-SP). 00000003306EN8 (São Paulo-SP). 00000310682CN0 (Porto Alegre, RS); 00001002103YM8 (Santana-RS); 00000004411PT5 (Goiânia-GO). 00000004411PT5 (São Paulo-SP). 00000003310EN0 (São Paulo-SP). 00000383739CN0 (Pouso Alegre-MG). The following CT scanners are affected by this field action. - LightSpeed ​​Ultra (MDAS of 8 cuts), LightSpeed ​​Plus (MDAS of 4 cuts), LightSpeed ​​QX / i (MDAS of 4 cuts) and LightSpeed ​​16 (only MDAS) ... The following CT scanners are affected by this field action. - Discovery ST and Discovery LS. 2016-02-19 Brazil ANVISA
Alerta De Seguridad para Discovery MR 750 3.0T model Discovery MR 750 3.0T, registration 80071260110 and Image and Magnetic Resonance Imaging System, Discovery MR 750w 3.0T model, registration 80071260134, hazard class II, lot / series 0000040-4-0161; 0000033-4-0161; 0000034-4-0152; 000032E-4-0181; 0000040-4-0146; 0000033-4-0145; 0000034-4-0139; 000032E-4-0160; 0000040-4-0258; 0000033-4-0261; 0000034-4-0242; 000032E-4-0313; 0000004-4-0242; 0000040-4-0439; 0000033-4-0443; 000032E-4-0554. 2016-02-25 Brazil ANVISA
Alerta De Seguridad para Commercial Name: Videoduodenoscopes // Registration Number Anvisa: 10371280029 // Risk Class: II Medium Risk // Model Affected: ED-3490TK // Serial Number Affected: H110761, H110763 and H110765 2016-03-09 Brazil ANVISA
Alerta De Seguridad para VIDEODUODENOSCOPE, model TJF-Q180V, registration 80124630021, risk class II, various batches / series 2101238, 2101449, 2101548, 2101553, 2101599, 2101631, 2101831, 2202550, 2202634, 2203238, 2203353, 2203354, 2203356, 2303564, 2303904, 2303905 , 2303982, 2304251, 2304251, 2304485, 2304485, 2304485, 2304485, 2404994, 2405413, 2405415, 2405420, 2405423, 2405753, 2505982, 2505997, 2506057, 2001123, 2101369, 2101345, 2101598, 2101600, 2404998, 2505898, 2505892, 2506636, 2506609, 2507086 , 2507076, 2507023, 2506640, 2507137, 2507120, 2507134, 2507122. 2016-03-03 Brazil ANVISA
Alerta De Seguridad para On Board Imager / VARIAN RADIOTHERAPY SYSTEM with CBCT, Versions 1.4, 1.5 and 1.6 with CBCT 2.1.05 SP1-SP6, registration 10405410011, risk class III, lots / series H074200; H073676; H074373; H074390; H070897; H071472; H071657; H070418; H074494; H073721; H073249; H072087; H071455; H074151; H074298. 2016-02-29 Brazil ANVISA
Alerta De Seguridad para Cobas p 512 Pre-Analytical System, records 10287411043 and 10287410844, hazard class I, various series: 4700920; 4701020; 4701430; 4706631; 4706731; 4706831; 4706931; 4707031; 4707131; 4707231; 4707331; 4707431; 4707631; 4707831; 4708131; 4709431; 4709531; 4709631; 4709731; 4709831; 4709931; 4,710,231; 4,710,331; 4,714,441; 4,717,943; 4,719,644; 4,725,245; 4,725,345; 4,762,545; 4,727,745; 4,728,145; 4,728,245; 4,728,545; 4,730,345; 4,730,645; 4,732,745; 4,733,045; 4733245; 4,733,645; 4,733,745; 4,733,845; 4,734045; 4,735,345. 2016-03-04 Brazil ANVISA
Alerta De Seguridad para Products affected by the Field Action: (i). Cardioversor Life 400 Plus Futura - Registration: 80058130010 - Class III; (ii). Cardioversor Vivo - Registry: 80058130015 - Class III. DISTRIBUTION MAPS (IN BRAZIL AND TO THE EXTERIOR) AND SERIES AFFECTED IN ANNEX. 2016-03-15 Brazil ANVISA
Alerta De Seguridad para The products affected by this field action are registered in ANVISA as: (i). Aisys Anesthesia System (Registration 80071260326) - Aisys CS2 Model; (ii). Aisys Anesthesia Machine (Registration 80071260272) - Aisys Model. Thus, all Aisys CS2 anesthesia devices (GTIN: 840682102292) and upgraded AISYS anesthesia devices (ie Aisys touch screen devices and 10.X software version) are affected. Software versions other than 10.X are not affected. DISTRIBUTION MAP IN ANNEX. 2016-02-26 Brazil ANVISA
Alerta De Seguridad para Product Affected by Field Action: SynchroMed II Deployable Infusion Pump (Registration 10339190229) Models 8637-20, 8637-40 - Risk Class IV. DISTRIBUTION MAP IN ANNEX. 2016-02-29 Brazil ANVISA
Alerta De Seguridad para Products Affected :. Product VITROS® Immunodiagnostic Reagent Kit for β-hCG II Total --Register no. 80145901052 -> Code 6802220 -> Lots 1410, 1420, 1430, 1440, 1450, 1460, 1470 -> Class II. VITROS® Immunodiagnostic Calibrators for β-hCG II Total --Register nº80145901051 -> Code 6802221 -> Lots 1410, 1420, 1430, 1440, 1450, 1460, 147 -> Class II 2016-03-21 Brazil ANVISA