Tecnología Médica

Tecnología Médica

Guidance Document: The Regulatory Enrolment Process (REP): Medical Devices
28/02/2024 - The objective of this document is to provide operational direction and guidance to companies on the requirements for the preparation and filing of regulatory activities for Medical Devices via the...
Wearable Breast Pumps
28/02/2024 - Momcozy wearable breast pumps were sold in the Canadian market without the proper authorization (i.e., medical device licence [MDL]). Update: The Momcozy wearable breast pump was issued a medical...
Alerta 4414 (Tecnovigilância) - Comunicado da empresa 3M do Brasil LTDA - Máquina de Tricotomia com Cabeça Rotativa (80284930396); Tricotomizador com Cabeça Rotativa (80284930377).
28/02/2024 - As instruções de uso do aparelho não asseguram a conformidade com a norma IEC 60601-1, incluindo a temperatura potencial máxima das lâminas de corte quando em...
Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices
23/02/2024 - Background - EURL designation 2023 In July 2022, the European Commission launched a call for the designation of EU reference laboratories in 8 categories of class D devices. Applicant...
Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels: FDA Safety Communication
22/02/2024 - Do not use smartwatches or smart rings to measure blood glucose. They are not authorized by the FDA. Using them could result in inaccurate blood glucose measurement, which can lead to serious...
La AEMPS informa de la retirada del mercado de determinados lotes de la muleta con puño anatómico blando y con referencia AD112
22/02/2024 - La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha tenido conocimiento, a través de la autoridad competente alemana, de un riesgo de seguridad relacionado con...
Synapse Picture Archiving And Communications Systems
16/02/2024 - Fujifilm has become aware that measurements on a secondary capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a breast tomo series results in incorrect...
Care Plus Incubator
16/02/2024 - GE Healthcare has become aware that the bedside panel of the incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not...
Philips Recalls BrightView Imaging Systems Due to the Detector Unexpectedly Falling
16/02/2024 - If the detector support component fails, imaging cannot be completed, and the detector may contact the patient.
Alerta 4409 (Tecnovigilância) - Comunicado da empresa Philips Medical Systems Ltda - Equipamento para Angiografia Allura Xper; Azurion.
15/02/2024 - A Philips tomou conhecimento de problemas com três (3) componentes em determinados PCs usados com os sistemas Philips Allura Xper, Allura Centron e/ou Azurion que podem resultar em perda de...
Novothor
15/02/2024 - Three Novothors had failed ball studs that sheared off (26 April 2018). When this occurs, the gas strut on one side of the Novothor becomes detached from the canopy, making the canopy difficult to...
Disposición N° 809/2024
14/02/2024 - Prohíbese el uso, comercialización y distribución en todo el territorio nacional de los productos médicos identificados como:”Facoemulsificador Sovereign Compact...
Disposición N° 846/2024
14/02/2024 - Prohíbese el uso, la comercialización y la distribución en todo el territorio nacional de todos los lotes/series del equipos de uso profesional identificado como “Equipo...
Alerta 4407 (Tecnovigilância) - Comunicado da empresa Shimadzu do Brasil Comércio Ltda - Aparelho de Hemodinâmica e Angiografia.
14/02/2024 - Foi verificado que no colimador modelo F-50 descrito nesta notificação, há a possibilidade de uma pequena peça de chumbo se descolar/desprender da palheta do colimador...
Alerta 4406 (Tecnovigilância) - Comunicado da empresa Philips Medical Systems Ltda - Achieva; Equipamento de Ressonância Magnética Philips.
14/02/2024 - O adesivo de vedação Quadrature Body Coil (QBC) pode falhar criando bordas afiadas que podem entrar em contato com os pacientes. O selo QBC pode se soltar à medida que a mesa...
Duet External Drainage And Monitoring Systems
14/02/2024 - Medtronic is recalling Duet External Drainage and Monitoring System (EDMS) products due to the potential catheter disconnection from the patient line stopcock connectors. Recall start date: January...
MDCG 2024-2 - Procedures for the updates of the EMDN - February 2024
14/02/2024 - The European Medical Device Nomenclature (EMDN), as established by Article 26 of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 - In...
Alerta 4405 (Tecnovigilância) - Comunicado da empresa GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda - Incubadora Careplus; Incubadora para Recém-nascidos.
09/02/2024 - A GE HealthCare tomou conhecimento de que o painel da cama do Care Plus, Care Plus® Modelos 1000, 2000, 3000 e 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator...
Alerta 4404 (Tecnovigilância) - Comunicado da empresa Karl Storz Endoscopia Brasil Ltda. - Instrumental Cirúrgico Karl Storz; Instrumental Monopolar/Bipolar Karl Storz.
09/02/2024 - Verificou-se que não existem provas suficientes que demonstrem que o método de reprocessamento dos produtos foi adequadamente validado.
Atlan® A350
08/02/2024 - The recall is being initiated as the market surveillance activities revealed a few cases in which the internal backup battery failed spontaneously while the Atlan® is being operated without mains...
Airflow™, SafeSpot™ and Horizon™ Resuscitators
08/02/2024 - Sunmed Holdings LLC (also trading as Ventlab LLC) is updating its IFU for the manual resuscitators to include a warning statement. A safety bulletin was issued relative to the use of accessories...