Tecnología Médica
Mapa TecMedTecnología Médica
Primus and Zeus Infinity Aneasthetic Workstations
27/08/2024 -
The O2 gas inlet and the O2 gas outlet may be confused when the customer assembles the pressure reducer for a reserve gas cylinder when using the "rs O2 connector". Recall start...
CADD-Solis Ambulatory Infusion Pump - Battery Pack
21/08/2024 -
Smiths Medical identified three (3) reports in which damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame...
Alerta 4558 (Tecnovigilância) - Comunicado da empresa Fresenius Medical Care Ltda - multiFiltratePRO.
21/08/2024 -
Durante as atividades de desenvolvimento de produtos, foi identificado um erro de software durante o teste funcional inicial (T1) da máquina multiFiltratePRO (Registro Anvisa: 80133950134),...
CARDIOVIT® AT-180 Electrocardiographs
21/08/2024 -
Occasionally high-frequency signal artifacts are recorded during an ECG acquisition performed by CARDIOVIT® AT-180 electrocardiographs. It has been observed that these high-frequency artifacts...
BioPince™, BioPince™ Ultra and Tru-Core™ II automatic biopsy instruments
20/08/2024 -
A complaint was received regarding a small hole in the sterile barrier tray that is utilized for three products, BioPince™, BioPince™ Ultra and Tru-Core™ II automatic biopsy...
Alerta 4549 (Tecnovigilância) - Comunicado da empresa Dräger Indústria e Comércio Ltda - Infinity M540.
19/08/2024 -
A Draeger Medical Systems, Inc. (DMSI) tomou conhecimento, durante os testes realizados em conjunto com nossas atividades de vigilância do mercado global, de que a estação de...
Alerta 4545 (Tecnovigilância) - Comunicado da empresa Becton Dickinson Indústrias Cirúrgicas Ltda - BD Bactec™ MGIT™ 960 PZA KIT.
15/08/2024 -
Através de tendências internas de reclamações da BD e subsequentes testes internos de matérias-primas, foi identificado que os kits BD Bactec™ MGIT™...
Alerta 4538 (Tecnovigilância) - Comunicado da empresa GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda - Centricity High Acuity Anesthesia (80071260410); Centricity High Acuity Critical Care (80071260406).
14/08/2024 -
A GE HealthCare tomou conhecimento da possibilidade de haver mal-entendidos nos valores de dosagem na janela de registro do aplicativo CHA ao usar o módulo de pedido. Especificamente, a...
Disposición N° 5635/2024
12/08/2024 -
Prohibir uso, comercialización y distribución en todo el territorio nacional de los productos identificados como: SOPRANO ICE SN S12P1261, SOPRANO ICE SN S12P1367, Cabezal Alma For...
Disposición N° 5960/2024
12/08/2024 -
Prohíbese el uso, comercialización y distribución en todo el territorio nacional de todos los lotes y modelos de los productos médicos: 1.- Kit de Procedimiento...
Disposición N° 5964/2024
08/08/2024 -
Prohíbase el uso, la comercialización y la distribución en todo el territorio nacional de todos los tamaños y modelosde los siguientes productos: “ASA TALLO LARGO...
Disposición N° 5961/2024
08/08/2024 -
Prohíbese el uso, comercialización y distribución en todo el territorio nacional del producto identificado como: “ELECTRONIC BLOOD PRESSURE MONITOR – Wrist type...
Disposición N° 5963/2024
08/08/2024 -
Prohíbese el uso, comercialización y distribución en todo el territorio nacional del producto identificado como: “MEDICALFIT Radiofrecuencia + ultracavitador”,...
Disposición N° 6246/2024
07/08/2024 -
Prohíbese el uso, comercialización y distribución en todo el territorio nacional de todos los lotes/series de todos los equipos identificados como: “RADIOFRECUENCIA...
Wireless Battery Module
02/08/2024 -
Baxter Corporation is issuing an urgent medical device correction for the Wireless Battery Modules (WBMs) used with Spectrum V8 and Spectrum IQ infusion pumps. Baxter is releasing a WBM software...
Karl Storz Telescopes
02/08/2024 -
Device identifiers listed are currently sourced from another Karl Storz subsidiary in the US. Their IFU was changed as part of an update to their 510(k). The IFU for these devices previously...
Detachable Endo Pocket
01/08/2024 -
The tube inside the pouch which detaches during the removal process may stretch out from the pouch opening if it is not precisely fixed during the production process. The stretching tube does not...
Mega 2000™ and Mega Soft™ Patient Return Electrodes - Potential Risk of Patient Burn Injuries
01/08/2024 -
Megadyne has received reports of patient and healthcare professional burns during or after surgical procedures in which Mega 2000 and Mega Soft Patient Return Electrode pads were used. Megadyne, in...
Alerta 4531 (Tecnovigilância) - Comunicado da empresa Philips Medical Systems Ltda - Software Philips Patient Information Center iX (PIC iX).
29/07/2024 -
A Philips tomou conhecimento de um possível problema de segurança relacionado à configuração personalizada do Catálogo de Eventos do Centro de...
Change Healthcare Cardiology
29/07/2024 -
Change healthcare has become aware of the use of an unapproved configuration involving misaligned regional settings between the server and client/browser. In certain workflows, this configuration...
Aurora, Aurora 2, Aurora 3, Aurora 4
29/07/2024 -
The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching. Recall start...
