Tecnología Médica
Mapa TecMedTecnología Médica
Update - Rev 1 - MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements - November 2023
30/11/2023 -
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member...
Alerta 4322 (Tecnovigilância) - Comunicado da empresa Becton Dickinson Indústrias Cirúrgicas Ltda - BD Alaris GP Equipos de Infusão para Oncologia para Uso com Bomba de Infusão.
30/11/2023 -
Foi identificado que há uma divergência no rótulo do produto, onde é indicado que “DEHP or Natural Rubber Latex are not part of the material formulation”...
Alerta 4321 (Tecnovigilância) - Comunicado da empresa Stryker do Brasil Ltda - Desfibrilador Automático Externo Samaritan PAD.
30/11/2023 -
Os itens afetados podem ficar inoperantes devido a células de bateria esgotadas. Como resultado, os Pad-Paks afetados podem potencialmente falhar ao ligar o dispositivo, se...
FDA Cautions Public of Safety Issue with Philips’ DreamStation 2 CPAP Machines
29/11/2023 -
FDA Cautions Public of Safety Issue with Philips’ DreamStation 2 CPAP Machines
Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication
29/11/2023 -
Reports of smoke, sparks, fire, and burns stemming from use of the DreamStation2 CPAP machines prompt warning from the FDA.
Maquet Cardiopulmonary Gmbh Perfusion Sets
29/11/2023 -
Maquet Cardiopulmonary Gmbh received customer complaints for custom tubing packs (CTP) reporting the perforation of the Tyvek, the upper part of the sterile barrier of the packaging. Upon further...
FDA Roundup: November 28, 2023
29/11/2023 -
FDA Roundup: November 28, 2023
Nim Trivantage Emg Endotracheal Tube
29/11/2023 -
Medtronic has received 87 complaints as of October 5th, 2023 indicating potential health hazards of degraded or loss of functionality of the device with specific lots. The potential hazards can...
Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication
29/11/2023 -
A voluntary recall initiated by SoClean for use of SoClean2 and SoClean3 equipment to clean, sanitize or disinfect CPAP devices and accessories.
Medfusion 3500 Syringe Infusion Pumps
28/11/2023 -
Smiths Medical identified legacy software anomalies which may occur in the Medfusion 3500 syringe infusion pumps. the legacy software anomalies were identified during a historical review of the risk...
Video Telescope - Endoeye HD II
28/11/2023 -
Olympus has identified a total of 1003 complaints, including 372 adverse events (since September 2020 to August 2023) related to pink or green coloration of the image, including cases with reported...
La AEMPS informa de la posibilidad de que el enchufe, de determinados números de serie, del sistema electrónico del paciente CardioMEMS pueda deteriorarse si se manipula o dobla repetidamente
28/11/2023 -
Formato pdf Fecha de publicación: 23 de noviembre de 2023 Categoría: productos sanitarios, seguridad Referencia: PS, 46/2023 Este problema afecta únicamente a algunos...
Philips Allura and Azurion
28/11/2023 -
Philips has identified a potential safety issue with the Philips Allura and Azurion product families having monoplane fixed ceiling mounted systems. The ceiling mounted l-arm contains a rotation...
Cranial Access Kit
28/11/2023 -
Through an internal investigation, it was identified that there is a defect in the outer packaging of the cranial access kits. This defect can cause the packaging to split without any additional...
Alerta 4317 (Tecnovigilância) - Comunicado da empresa Siemens Healthcare Diagnósticos Ltda - Família Sistema de Análise de Gases Sanguíneos - Rapidpoint (10345162346); Rapidpoint 500 System (10345161877).
23/11/2023 -
A Siemens Healthineers verificou que dois medicamentos, Maleato de Perhexilina e Cloridrato de Atomoxetina, podem interferir nos resultados de sódio reportados pelos Sistemas de Gasometria...
LIFEPAK® 15 AC Power Adapter
23/11/2023 -
Stryker Canada has identified an increase in number of complaints related to LP15 ACPA failures with the reported symptoms of "battery not charging" and "auxiliary power will not...
Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps
22/11/2023 -
Cardinal Health Monoject syringes have demonstrated recognition and compatibility issues with certain infusion pumps.
Alerta 4316 (Tecnovigilância) - Comunicado da empresa Elekta Medical Systems Comércio e Serviços Radioterapia Ltda - Acelerador Linear Elekta.
22/11/2023 -
Identificou-se que se o microinterruptor no braço intermediário estiver configurado incorretamente, existe a possibilidade de uma extensão descontrolada dos braços do...
LINQ II Insertable Cardiac Monitor (ICM)
22/11/2023 -
Medtronic is notifying customers of a population of LINQ II Insertable Cardiac Monitors (ICM) that underwent a manufacturing process that may allow for moisture to impact electrode performance....
FDA Roundup: November 21, 2023
22/11/2023 -
FDA Roundup: November 21, 2023
