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...
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...
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...
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 "/"...
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...
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...
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...
Alerta 4451 (Tecnovigilância) - Comunicado da empresa Diamed Latino América S.A. - IH-500.
12/04/2024 -
Foi identificada uma anomalia com o Arquivo de Protocolo de Teste (APF – Assay Protocol File) “Titra 1/128 37C IAT: DiaCell A1-B (5054)” (TIGG128) destinado a realizar um teste...
Ultrasound System 5500 and 5500CV
10/04/2024 -
If, during a procedure where multiple transducers are connected to the compact 5000, one of which is a transesophageal echocardiography (TEE) transducer and imaging is being performed with one of the...
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...
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...
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...
Terumo Cardiovascular Procedure Kits
03/04/2024 -
CHS initiated this recall after receiving a notification from Terumo on their cardiovascular procedure kits that include high crack check valve. Terumo cardiovascular systems (Terumo CVS) has...
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...
