Tecnología Médica

Tecnología Médica

Baxter Healthcare Corporation Recalls Volara System For Risk Of Respiratory Distress In Ventilated Patients During Home Use
24/06/2022 - When the Volara system’s in-line ventilator adaptor is used at home with a ventilator, it may prevent the patient from getting enough oxygen.
Modular Cathcart Fracture Head
24/06/2022 - During an internal review, it was determined that the Cathcart head includes a +5mm offset, which was not specified in previous versions of the self-centering bipolar and Modular Cathcart unipolar...
Zero Footprint Client
24/06/2022 - GE Healthcare has become aware of two issues related to a potential to display inaccurate measurements on images in centricity universal view Zero Footprint Client (zfp). Recall start date: June...
Alerta 3889 (Tecnovigilância)
24/06/2022 - Comunicado da empresa Roche Diagnóstica Brasil Ltda - Ventana HE 600 System – Vazamento de fluido - Atualização de software e correção em campo.
Medtronic Recalls HeartWare HVAD System Batteries Due to Battery Failure
24/06/2022 - The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging.
Alerta 3887 (Tecnovigilância)
23/06/2022 - Comunicado da empresa Dentsply Ind. Com. Ltda - Componentes Protéticos - Produto diferente do constante no rótulo – Recolhimento.
La AEMPS informa de la posible rotura de los pies protésicos Vari-Flex Junior cuando se les aplica una torsión o flexión repentina de alto impacto
23/06/2022 - La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha tenido conocimiento, a través del fabricante Össur hf, Islandia, de la posibilidad de que los pies...
Alerta 3888 (Tecnovigilância)
23/06/2022 - Comunicado da empresa GE Healthcare do Brasil, Com. e Serv. para Equip. Ltda. - Sistema de Anestesia Aisys e Avance - Potencial inversão da conexão do transdutor de pressão do cilindro de O2 e ar...
BD Announces Voluntary Recall on Intraosseous Products
23/06/2022 - BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on the BD Intraosseous Needle Set Kits, BD Intraosseous Manual Driver Kits and BDTM...
FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication (UNPUBLISHED)
22/06/2022 - The FDA is issuing this safety communication to alert health care providers and patients about issues that may cause batteries in certain Medtronic implantable pacemakers or cardiac...
Alerta 3886 (Tecnovigilância)
21/06/2022 - Comunicado da empresa Abbott Laboratórios do Brasil Ltda - Família Instrumento Alinity hq System (80146502148) / Família Instrumento Alinity hs (80146502143) - Resultados incorretos -...
Minimed Pump battery cap
21/06/2022 - Notification to inform customers of a potential issue relating to pump's battery cap and provide actions required by the customers. Notification advises customers that if the metal contact becomes...
Aisys Cs2
21/06/2022 - The affected anesthesia systems base can have a crack in a specific location in the rear of the system. If excessive load is applied to the device, a cracked base could potentially fracture,...
La AEMPS actualiza su Carta de Servicios para el periodo 2022-2025
21/06/2022 - La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha actualizado su
Hydro-Surg Plus Laparoscopic Irrigators
21/06/2022 - Certain lots of the products are not able to provide irrigation. Recall start date: June 7, 2022
Disposición N° 4365/2022
16/06/2022 - Establécese que el mantenimiento de la inscripción en el “Registro de Productores y Productos de Tecnología Médica” de los Productos Médicos...
Disposición N° 4358/2022
16/06/2022 - Prohíbese el uso, comercialización y distribución en todo el territorio nacional del equipo para electroestimulación con ondas rusas, cuadradas, tens, modelo...
UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers
16/06/2022 - The FDA provides updated information from our ongoing evaluation of NTM infections in patients who have had cardiothoracic surgery using heater-cooler devices.
Alerta 3884 (Tecnovigilância)
16/06/2022 - Comunicado da empresa GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda - Sistema de Anestesia Carestation - falha do misturador. Correção em Campo. Correção de...
MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements
15/06/2022 - With the adoption of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), the regulatory framework for medical devices and in vitro diagnostic medical devices (IVD) has changed significantly. The...
Información sobre un posible problema con el tapón de la pila de las bombas de insulina MiniMed™ de la serie 600 y 700
15/06/2022 - La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha tenido conocimiento, a través de la empresa Medtronic Iberica S.A., España, de que en determinadas bombas...