Tecnología Médica

Tecnología Médica

Disposición N° 8866/2022
25/11/2022 - Prohíbese el uso, la comercialización y la distribución en todo el territorio nacional del producto identificado como: “Sistema de Stent Periférico SUPERA Modelo:...
Disposición N° 8268/2022
10/11/2022 - Prohíbese el uso, comercialización y distribución en todo el territorio nacional de los siguientes productos: 1. Marcapaso Modelo: Evity 6 DR-T, número de serie...
Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Due to Shortage – Letter to Health Care Providers
01/11/2022 - The FDA recommends health care providers discuss alternatives for MRI-guided breast biopsies with patients due to shortage of Philips Invivo plates and disposables.
Disposición N° 7983/2022
18/10/2022 - Prohíbese el uso, la comercialización y la distribución en todo el territorio nacional del producto identificado como: “Válvula cardiaca mecánica...
G7 Acetabular Shell 3 Hole Osseoti, Cementless
17/10/2022 - Zimmer Biomet is conducting a lot specific medical device recall for of various G7 acetabular shells and liner due the outer sterile cavity having the potential to be below the minimum wall...
Large Bone Shoulder Bolt
11/10/2022 - Bolt shearing at the head or on the threaded portion which may cause strut dissociation from the frame. No patient injury, delay in surgery or other adverse event resulted. Recall start date:...
La AEMPS informa de un problema de seguridad con determinadas mascarillas de Philips Respironics que contienen imanes que pueden afectar a implantes y dispositivos médicos
04/10/2022 - egory>Acciones Informativas Notas informativas Productos Sanitarios seguridad Portada Seguridad Última información https://www.aemps.gob.es/?p=24358 Formato pdf Fecha de publicación: 30...
Disposición N° 7079/2022
15/09/2022 - Prohibese el uso, comercialización y distribución en todo el territorio nacional de todos los lotes del producto identificado como “Silvernail Implantes RB S.R.L. COLUMNA,...
Abbott MitraClip Device: Potential for Clip Lock Malfunctions – Letter to Health Care Providers
12/09/2022 - There are reports of clip lock malfunctions before and after clip deployment with the Abbott MitraClip device.
Abbott MitraClip Device: Potential for Clip Lock Malfunctions – Letter to Health Care Providers
09/09/2022 - There are reports of clip lock malfunctions before and after clip deployment with the Abbott MitraClip device.
Power Knee
09/09/2022 - Össur received reports of a small number of units where the battery dislodged from the power knee unit, causing loss of power to the device. The decision to conduct a medical device...
Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication
09/09/2022 - Reports of squamous cell carcinoma and various lymphomas in capsule around breast implants. Read recommendations for patients and health care providers
Medtronic Recalls HeartWare HVAD System Batteries for Electrical Faults That Cause Battery Failure
26/08/2022 - An electrical fault may cause the batteries of the HeartWare HVAD System to fail, leading to severe injury or death.
Alerta 3939 (Tecnovigilância)
23/08/2022 - Comunicado da empresa Auto Suture do Brasil LTDA - Comunicador; Neuroestimulador Implantável para Estimulação Cerebral Profunda. Anormalidade no aplicativo do programador do médico. Atualização...
Vanta Clinician Programmer Application
23/08/2022 - Notification to inform customers that in rare instances (0.085%) during initial programming, the Vanta CP app will display the error code 1502 message because the Vanta INS reset block id log is...
Vanta/Sequentia Lt Clinician Programmer Application
23/08/2022 - Connection issue for Vanta pain pc implantable neurostimulators when transplanted in the same patient. "Too many devices" error will appear from Clinician Programmer Application (CPA)...
Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy
22/08/2022 - Cobalt/Crome ICDs and CRT-Ds may deliver reduced-energy electric shocks and short circuit protection (SCP) alerts during high voltage therapy.
Alerta 3937 (Tecnovigilância)
22/08/2022 - Comunicado da empresa Auto Suture do Brasil Ltda - Stent Periférico Everflex Entrust. Atualização nas Instruções de Uso (IFU). Comunicação aos clientes.
Alerta 3925 (Tecnovigilância)
08/08/2022 - Comunicado da empresa Cardinal Health do Brasil - Smart Flex Vascular Stent System 5 - 8 MM (81356112255); Smart Flex Vascular Stent System 9 - 10 MM (81356112258) – Potencial desconexão ponta...
Activa Clinician Programmer Application For Deep Brain Stimulation
08/08/2022 - A system error and termination of program may occur. This may occur when a patient was previously programmed with an A610 dbs clinician programmer application v.2.0.x or later, and later the same...
Alerta 3920 (Tecnovigilância)
03/08/2022 - Comunicado da empresa Medtronic Comercial Ltda - Heartware - Sistema de Assistência Ventricular - Problemas no desempenho do produto relacionados às Baterias. Comunicação aos clientes.