Tecnología Médica
Mapa TecMedTecnología Médica
IMPRESCINDIBLE
A Study and dashboard on reprocessing and reuse of single-use-devices in the EU
11/04/2024 -
The study started in December 2022 and was performed over 14 months. The study main objective is to evaluate how the provisions established in the MDR have been implemented in European countries and how such provisions operate.
Syntel Silicone Thrombectomy Catheter
23/04/2024 -
It has been reported that during the use of the Syntel Silicone Thrombectomy Catheter, the guide tip (not the balloon or catheter) can become damaged and result in the tip detaching.
Recall start...
Nexgen CR-Flex Femoral Component, Size E And Size E Minus (E-)
18/04/2024 -
Zimmer Biomet is conducting a lot specific medical device recall for Nexgen CR-flex femoral components, size E and size E minus (E-) . This recall is due to an out of specification violation that...
La AEMPS informa sobre la detección de un certificado de marcado CE falsificado de la empresa Guanzhou Yueshen Medical Equipment
18/04/2024 -
La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha recibido una comunicación de las autoridades sanitarias alemanas relativa a la detección de un...
MDCG 2024-5 - Guidance on the Investigator’s Brochure content - April 2024
18/04/2024 -
When a sponsor of a clinical investigation shall submit an application according to article 70(1) of the MDR, the application shall be accompanied by the documentation referred to in Chapter II of...
Alerta 4455 (Tecnovigilância) - Comunicado da empresa Smiths Medical do Brasil Produtos Hospitalares Ltda - Ventiladores Parapac Plus.
18/04/2024 -
Quando um ventilador paraPAC plusTM é alternado para o modo de operação ‘Ventilar’, os ventiladores paraPAC plusTM podem fornecer intermitentemente fluxo de...
Powerseal Curved Jaw Sealer & Divider Double Action
18/04/2024 -
Olympus (Gyrus Acmi, Inc.) is initiating a medical device recall action and notifying affected customers after a retrospective review identified a total of nine (9) Powerseal units determined to be...
La AEMPS participa en la acción europea JAMS 2.0 para llevar a cabo inspecciones conjuntas de productos sanitarios
18/04/2024 -
La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) participa en
Alerta 4454 (Tecnovigilância) - Comunicado da empresa Síntegra Surgical Sciencies Ltda - SinBone n.
17/04/2024 -
Publicação da RE n. 315 de 25 de janeiro de 2024, determinando o cancelamento do registro do produto. Cancelamento teve como origem uma reavaliação do processo de...
Universal Viewer
17/04/2024 -
Images from two different patients may be contained in a single study when stored in Centricity PACS-IW V3.7.X, Centricity PACS-IW with Universal Viewer V5.0 or Centricity Universal Viewer V6.0...
La AEMPS informa de un defecto en el firmware de las rodillas biónicas Rheo Knee y Rheo Knee XC
17/04/2024 -
La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha tenido conocimiento, a través de la empresa islandesa Össur hf., de un defecto en la versión...
Rheo Knee and Rheo Knee XC
17/04/2024 -
In October 2023 a defect was identified in firmware version BRK3.02.17 which is causing unintended device warnings. In some cases, the warnings trigger device shutdown. Depending on how the...
Alerta 4453 (Tecnovigilância) - Comunicado da empresa DGS Brasil Ltda - Deepunity Diagnost.
16/04/2024 -
O uso de "/" em um nome de estação de trabalho leva a uma falha do sistema. A criação de uma estação de trabalho com o caractere "/"...
Alerta 4452 (Tecnovigilância) - Comunicado da empresa Fresenius Medical Care Ltda - Extensão para Cateter.
16/04/2024 -
O Fabricante, após a realização de testes internos, constatou a presença de ácidos bifenílicos policlorados (PCBAs) não semelhantes à...
MDCG 2024-4 - Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 - April 2024
15/04/2024 -
Safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) shall be performed in line with the requirements of Article 76(2) of Regulation (EU) 2017/746 – In Vitro...
La AEMPS informa de un problema de seguridad relacionado con las mascarillas respiratorias con imanes de Sleepnet Corporation
15/04/2024 -
La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha tenido conocimiento, a través del fabricante Sleepnet Corporation, EEUU, de nuevas contraindicaciones y...
Update - MDCG 2022-9 rev.1 - Summary of safety and performance template - April 2024
15/04/2024 -
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices,...
Blood Pressure Unit
12/04/2024 -
It has been determined that certain blood pressure monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as...
