Tecnología Médica
Mapa TecMedTecnología Médica
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...
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...
Intellivue -Information Centre
12/04/2024 -
The ups devices are backup batteries utilized by PIC IX central monitoring stations and their associated hardware components. These devices are intended to provide power to the PIC IX system or...
Airlife Adult Manual Resuscitator
08/04/2024 -
Vyaire has received thirty-seven (37) customer reports relating to product issues, including two deaths and two serious injuries. It has been identified that the affected product issues are due to...
Medline Industries Scissors and Forceps
08/04/2024 -
This recall is due to having a weak seal, which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. Because of this failure and a...
Heartsine Samaritan PAD 360P, 500P, and 350P
05/04/2024 -
Stryker has determined that a manufacturing related issue may impair device audio prompts. Stryker is issuing a customer notification to remind customers to follow the user manual and power the...
Hugo Ras Tower, 120v
04/04/2024 -
There have been 22 complaints of reported communication errors with the Hugo™ Ras System. Medtronic determined that the errors were caused by specific ports on a network switch located on the back...
Hugo Ras Surgeon Console
03/04/2024 -
There has been 11 reported field failure incidents of power loss of main AC/DC power supply of Hugo Ras Surgeon Console. The power supply failure could lead to the permanent loss of ability to...
Rad-G Pulse Oximeters
03/04/2024 -
Masimo identified certain Rad-G devices powering off and on without pressing the power button. Masimo's investigation identified an issue that can result in an unintentional change in the...
Alerta 4449 (Tecnovigilância) - Comunicado da empresa VR Medical Importadora e Distribuidora de Produtos Médicos Ltda - Airflow Prophylaxis Master (80102512351); Airflow One (80102512352).
03/04/2024 -
A VR Medical foi informada pela fabricante E.M.S Electro Medical que os componentes, EG-121 Water bottle (data de validade 04-2026 / 07-2026 / 10-2026), EG-120 Night Cleaner bottle (data de...
Olympus Medical Single Use Electrosurgical Knives
25/03/2024 -
Olympus is initiating a recall to inform customers of an increase in complaints for the triangle tip of the KD-640L and KD-645L triangle tip electrosurgical knives breaking off during use. Olympus'...
Perseus A500
15/03/2024 -
The recall is being initiated as the market surveillance activities revealed a few cases in which the internal backup battery failed spontaneously while the perseus device being operated without...
Disposición N° 1438/2024
14/03/2024 -
Prohíbese el uso, comercialización y distribución en todo el territorio nacional del equipo identificado como: “Alma Lasers - SOPRANO PLATINUM – SN PLAT3124...
Disposición N° 1344/2024
14/03/2024 -
Prohíbese el uso, comercialización y distribución en todo el territorio nacional de todos los lotes/series de todos los equipos de uso profesional identificados con la marca...
Disposición N° 1343/2024
14/03/2024 -
Prohíbese el uso, comercialización y distribución en todo el territorio nacional de todos los lotes y/o series de los siguientes productos: “ELECTRONIC BLOOD PRESSURE...
Various Olympus Medical Endoscopes
13/03/2024 -
As a result of catch up 510(k)s on the subject devices, the reprocessing instructions were changed. Specifically, the EtO gas mixture was revised to reflect the gas mixture that is commercially...
Disposición N° 1485/2024
13/03/2024 -
Prohibir el uso, la comercialización y la distribución en todo el territorio nacional de las bombas de infusión que se detallan a continuación: Bomba de Infusión...
Disposición N° 1487/2024
13/03/2024 -
Prohibir el uso, la comercialización y la distribución en todo el territorio nacional de los productos: Bomba para alimentación enteral identificadas como COVIDIEN KANGAROO...
Alerta 4431 (Tecnovigilância) - Comunicado da empresa Medix Brasil Ltda - Medix Brasil Eletrodos Descartáveis para ECG.
12/03/2024 -
Os lotes inclusos na ação de campo estão ligados a ocorrências de reclamações referentes à interferência de leitura e problemas de...
Alerta 4430 (Tecnovigilância) - Comunicado da empresa Medix Brasil Ltda - Medix Brasil Eletrodos Descartáveis para ECG.
12/03/2024 -
Os lotes inclusos na ação de campo estão ligados a ocorrências de reclamações referentes à interferência de leitura e problemas de...
