Tecnología Médica

Tecnología Médica

ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical Devices
22/01/2024 - ResMed Ltd. recalls AirFit & AirTouch masks due to possible magnetic interference with certain medical devices. ResMed is updating the labels for safer use.
Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
22/01/2024 - Recalled masks have magnets that can cause injuries or death when the mask is near certain implanted metallic medical devices or metallic objects in the body.
La AEMPS informa sobre la detección de un certificado de marcado CE falso de la empresa Ideal Makina Endüstri Ürünleri San. ve Tic. A.S.
22/01/2024 - La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha recibido una comunicación de las autoridades sanitarias rumanas respecto a la detección de un certificado...
Oxy2Mask
22/01/2024 - There is a potential for the elbow component to not be securely connected to the diffuser component. This originated from a complaint received on November 15, 2023. Recall start date: January 5,...
ResMed Notifies Customers About Updated Instructions and Labeling for Masks with Magnets Due to Potential Interference with Certain Medical Devices
26/12/2023 - ResMed (NYSE: RMD, ASX: RMD) is conducting a voluntary global field action to update its guides for all masks with magnets to inform users about potential magnetic interference when magnets are...
La AEMPS informa de un problema de seguridad relacionado con las mascarillas respiratorias con imanes de ResMed
19/12/2023 - La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha tenido conocimiento, a través de la empresa ResMed SAS, Francia, de la actualización de las...
Airtouch and Airfit ResMed Masks
15/12/2023 - Under certain circumstances when a magnet in a Resmed mask(s) is in close proximity to certain medical implants/devices, potential magnetic interference could affect the performance or implanted...
Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication
29/11/2023 - A voluntary recall initiated by SoClean for use of SoClean2 and SoClean3 equipment to clean, sanitize or disinfect CPAP devices and accessories.
FDA Cautions Public of Safety Issue with Philips’ DreamStation 2 CPAP Machines
29/11/2023 - FDA Cautions Public of Safety Issue with Philips’ DreamStation 2 CPAP Machines
Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication
29/11/2023 - Reports of smoke, sparks, fire, and burns stemming from use of the DreamStation2 CPAP machines prompt warning from the FDA.
Alerta 4266 (Tecnovigilância) - Comunicado da empresa VR Medical Importadora e Distribuidora de Produtos Médicos Ltda - Concentrador de Oxigênio.
25/09/2023 - A VR Medical foi comunicada, pela Fabricante Caire, sobre a utilização da etiqueta de nacionalização realizada pelo fabricante com o número de...
Maquet Perfusion Pack
18/09/2023 - There was a gas filter used in a fluid bearing line of the custom tubing pack. All computed tomography perfusion (CTPs) that were manufactured before the introduction of the new filter type and have...
Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening Properly
13/09/2023 - The One-Way Valve, 22F x 22M is a single-use device accessory used to prevent backward flow of nitric oxide gas into the airways.
Philips BiPAP and Humidifiers
26/07/2023 - There is currently a non-conformance regarding the disinfection method recommended in the instructions manual for devices in the field, as the Keredusy disinfection method was not adequately...
Oxygenator Devices Used for Extracorporeal Circulation – Letter to Health Care Providers
12/06/2023 - Learn about the issue, the FDA’s recommendations and actions, how to report a problem, and contact information.
Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy
10/04/2023 - Certain Philips Respironics DreamStation CPAP and BiPAP Machines are recalled because they may not deliver the right correct amount of breathing support.
Baxter Issues Urgent Medical Device Correction for LIFE2000 Ventilation System Due to Potential for Patient Desaturation When Connected with an Oxygen Concentrator
13/03/2023 - Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Life2000 Ventilation System due to the potential for patient oxygen desaturation (low blood...
Capiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter
13/03/2023 - Terumo Cardiovascular Systems (Terumo CvS) has discovered that some Capiox NX, RX and FX oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port....