Tecnología Médica
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Share your views: Updates made to list of recognized standards for medical devices and draft guidance
26/07/2024 -
Health Canada invites you to comment on proposed changes to the guidance on the list of recognized standards for medical devices.
Current status: Open
Opened on July 25,...
Notice on Health Canada's proposed changes to the guidance on recognized standards for medical devices
26/07/2024 -
Notice on Health Canada's proposed changes to the guidance on recognized standards for medical devices.
About the consultation
We're looking for feedback on the updates...
Maquet Quadrox-i Oxygenators and Perfusion Packs
26/07/2024 -
Potential for a foreign particle in the VHK 71000 reservoir. This reservoir can be stand alone or a component in several different custom tubing packs. The issue is limited to products...
Medtronic XPS System - Burs
26/07/2024 -
Due to a distribution error, a single expired unit of XPS System - BUR 31313069U Ultra EA 3mm long length was shipped. Recall start date: July 5, 2024
Alerta 4529 (Tecnovigilância) - Comunicado da empresa VR Medical Importadora e Distribuidora de Produtos Médicos Ltda - Grampeador Linear Cortante Endoscópico Articulado Motorizado Descartável e Recargas.
26/07/2024 -
A VR Medical identificou uma duplicidade na utilização do selo de conformidade Inmetro. O modelo DSML60 e lote LA16D1, do equipamento registro 80102512602, apresentam dois selos de...
Philips BIPAP A40 Pro ventilators
25/07/2024 -
Philips Respironics has become aware of a potential safety issue with all BIPAP A40 Pro ventilators. The ventilator may incorrectly generate a "high internal oxygen" alarm....
Alerta 4527 (Tecnovigilância) - Comunicado da empresa Philips Medical Systems Ltda - Equipamento de Raio-X.
25/07/2024 -
A Philips recebeu reclamações relacionadas a problemas de segurança que pode ocorrer com os sistemas de raios-X de pêndulo compacto se a manutenção...
McGRATH™ MAC Video Laryngoscope
25/07/2024 -
Medtronic is issuing a voluntary recall for item code 300-000-000 (section 1). This notice also includes information related to an addendum to the instructions for use (IFU) for item code...
Alerta 4523 (Tecnovigilância) - Comunicado da empresa Welch Allyn do Brasil, Comércio de Equipamentos Médicos Ltda - Escaneador Ocular.
22/07/2024 -
A Baxter está emitindo uma Correção Urgente de Dispositivo Médico para os cabos de alimentação usados com o monitor de visão Welch Allyn...
Level 1® Fast Flow Fluid Warmer and Level 1® NORMOFLO Irrigation Fluid Warmer
22/07/2024 -
Smiths Medical is issuing this letter to notify customers of a potential issue related to the Level 1 Fast Flow Fluid Warmers and Level 1 NORMOFLO Irrigation Fluid Warmers: 1. The return tube...
Alerta 4521 (Tecnovigilância) - Comunicado da empresa Getinge do Brasil Equipamentos Médicos Ltda - Sistema de Anestesia.
19/07/2024 -
A Maquet Critical Care AB recebeu reclamações onde foi observada descoloração/corrosão dentro do vaporizador sob condições normais de...
Titan Blis-Sonic SW Scaler
19/07/2024 -
A voluntary recall was initiated for a certain lot of Titan Scaler Tip-Perio (part number# 261669) specifically packaged with Blis-Sonic Scaler (part number# 264563) lot# 4874201 distributed...
DEFIGARD Touch 7
19/07/2024 -
In the past three years, six failures in the defibrillation shock delivery control circuit of the DEFIGARD Touch-7 have led to shocks not being delivered when the device is used. Recall Start...
Luminos Lotus Max, dRF Max, and Agile Max
19/07/2024 -
There is a potential problem with the support arm for the display ceiling suspension / display wall suspension. This issue may result in an injury to persons when they are under the display...
Alerta 4518 (Tecnovigilância) - Comunicado da empresa Philips Medical Systems Ltda - Equipamento de Tomografia Computadorizada.
17/07/2024 -
A Philips identificou um problema de hardware com uma caixa de acoplamento de metal no rotor do scanner rotativo (caixa do trocador de calor) localizado nos sistemas Incisive CT/CT 3500/CT 5300. A...
8694 - Laser Application Instrument, 23 Cm
15/07/2024 -
It was found that there is insufficient evidence to show that the reprocessing method of the products was adequately validated. This issue affects all lot numbers of the referenced Karl Storz article...
Arctic Sun 5000 and Arctic Sun Stat
15/07/2024 -
An internal investigation has determined that alarm 113 may not alert as expected when the device fails to reach the correct target water temperature while the device is operating in patient control...
Soltive Laser System
15/07/2024 -
Olympus investigated complaints received where customers reported difficulties in pairing the wireless footswitch with the Soltive laser, resulting in delays in surgical procedures or prolonged...
Signa MR Systems
12/07/2024 -
B1+RMS predicted value may exceed user prescribed limit in low SAR mode for certain MR systems.
Recall start date: June 14, 2024
Discovery, Signa and Optima MR Systems
11/07/2024 -
B1+RMS predicted value may exceed user prescribed limit in low SAR mode for certain MR systems.
Recall start date: June 14, 2024
Fabian Ventilators
11/07/2024 -
The manufacturer is providing an addendum to users with additional information that supplements and clarifies the existing IFUs for the following three topics to ensure safe and proper...
