Tecnología Médica
Mapa TecMedTecnología Médica
Sapphire Infusion Pump
28/09/2023 -
Due to a software issue, Sapphire Infusion Pump with SW Version 16.10.1 and 16.10.2 may sometimes fail to identify air in line (AIL). AIL may lead to air embolism. No complaints or patient harm...
Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023)
28/09/2023 -
The views expressed in this document represent the agreements reached by the competent authorities of the Member State members of the Borderline and Classification Working Group, a subgroup of the...
Hamilton-C2/C3/C1/T1 ventilators
27/09/2023 -
We have become aware of a malfunction with the Hamilton-C2/C3/C1/T1 ventilators when used long term in neonatal patient group. If an affected device is used accumulatively for 91 days in neonatal...
Alerta 4267 (Tecnovigilância) - Comunicado da empresa GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda - Família Giraffe Carestation.
25/09/2023 -
A GE HealthCare tomou conhecimento da possibilidade de que um tipo de trava secundária possa ter sido instalada nos painéis do leito nordeste (NE) e/ou noroeste (NW) para...
Alerta 4266 (Tecnovigilância) - Comunicado da empresa VR Medical Importadora e Distribuidora de Produtos Médicos Ltda - Concentrador de Oxigênio.
25/09/2023 -
A VR Medical foi comunicada, pela Fabricante Caire, sobre a utilização da etiqueta de nacionalização realizada pelo fabricante com o número de...
Solea
25/09/2023 -
In normal use, the laser is activated when the user sets the device to the "armed" state and when the foot pedal is depressed in the "armed" state. (the laser is deactivated when it is not in the...
Zimmer Dermatome Blades
25/09/2023 -
Zimmer Biomet Canada is initiating a lot specific recall for the Zimmer dermatome blades (00-8800-000-10) in Canada. There have been 38 complaints received related to skin grafts being thin and...
Evis Exera III Video System - Video System Center
25/09/2023 -
Olympus found that certain lots of the CV-190 do not start up properly and as a result, the image from the endoscope is not displayed when the operations listed below are performed because parts that...
Alerta 4264 (Tecnovigilância) - Comunicado da empresa Farmarin Indústria e Comércio Ltda - Linha de Sangue Venosa para Hemodiálise (80053109001); Linha de Sangue Arterial para Hemodiálise (80053100013); Conjunto de Circulação Assistida - Linhas de Sangue Farmarin (80053100015).
18/09/2023 -
A empresa informa que recebeu notificações relatando que a linha de sangue se desconectou do conector valvulado inserido no cateter venoso central durante o processo de...
Maquet Perfusion Pack
18/09/2023 -
There was a gas filter used in a fluid bearing line of the custom tubing pack. All computed tomography perfusion (CTPs) that were manufactured before the introduction of the new filter type and have...
Hugo™ Robotic-Assisted Surgery (RAS) Tower, 120v
18/09/2023 -
Reports of system error during preoperative calibration self-tests of the Hugo robotic arm cart assembly. After recalibration attempt, the robotic arm cart assembly will be prevented from entering...
Abbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic Resonance Imaging (MRI) Mode
14/09/2023 -
The Abbott Proclaim and Infinity neurostimulation systems deliver low-intensity electrical impulses to nerve structures. The device may be unable to exit MRI mode and resume...
Alerta 4263 (Tecnovigilância) - Comunicado da empresa Getinge do Brasil Equipamentos Médicos Ltda - Sistema de Apoio Coração-Pulmão.
14/09/2023 -
Verificou-se que a fixação (solda) empregada pelo fornecedor do parafuso da porca na placa do trilho deslizante foi insuficiente. A solda deficiente permite que o parafuso da porca...
Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening Properly
13/09/2023 -
The One-Way Valve, 22F x 22M is a single-use device accessory used to prevent backward flow of nitric oxide gas into the airways.
Alerta 4260 (Tecnovigilância) - Comunicado da empresa Getinge do Brasil Equipamentos Médicos LTDA - Mesa de Operações Móvel.
12/09/2023 -
Identificamos que um problema pode impedir que o dispositivo funcione conforme esperado. Uma sequência específica de comandos na unidade de controle ativa a transmissão de...
Magnetom MRI System
12/09/2023 -
Siemens Healthcare will be informing customers about potential dot- or line-shaped artifacts caused by the presence of lubricating grease within the headband of the over-ear headphones listed...
Alerta 4258 (Tecnovigilância) - Comunicado da empresa Olympus Optical do Brasil Ltda - Videoduodenoscopio.
12/09/2023 -
A Olympus está iniciando esta ação após tomar conhecimento de relatórios recentes de infecções e culturas positivas e consultas do FDA em...
Equipro High Frequency Portable (EI-113P)
12/09/2023 -
The Equipro High Frequency Portable EI-113P is non-compliant (not licensed for sale in Canada) as a Class II medical device under Canadian law. Further distribution or use of the remaining product...
Apical Coring Knife and Heartmate 3 Left Ventricular Assist System
12/09/2023 -
Starting in April 2023, Abbott has received complaints regarding inability of the Apical Coring Knife to start and/or complete resecting heart tissue when the physician was preparing the...
Enterprise 9000x With Indigo Module
12/09/2023 -
Arjo has observed an increasing complaint trend on the following failure modes occurring on Arjo medical beds assembled with the Indigo modules: unanticipated device self-acceleration while being...
Space Infusion System - Infusomat Space Volumetric Infusion Pump
08/09/2023 -
The pumps have the potential for the upstream occlusion sensor to cease proper function due to the build-up of electrostatic charge during operation triggering false downstream and upstream...
