Tecnología Médica
Tecnología Médica
Medical Devices Bureau Performance Quarterly Report for Q3 2022-2023
22/03/2023 -
Le rapports sur le rendement de la Direction des instruments médicaux pour le troisième trimestre 2022-23 fournissent des mesures détaillées sur le traitement des...
Consultation period extended until April 26, 2023 for proposed agile regulations and guidance for licensing drugs and medical devices
22/03/2023 -
The consultation period for the proposed Agile Regulations and Guidance for the Licensing of Drugs and Medical Devices has been extended by an additional 30 days. This consultation will now close...
Medical devices for use in relation to COVID-19 [2023-02-22]
22/03/2023 -
Guidance on regulations amending the medical devices regulations to continue the importation and sale of medical devices for use in relation to COVID-19.
Tubed medical devices and children
22/03/2023 -
Information about tubed medical devices for children including types, risks, managing the risks and reporting serious or adverse events.
Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown Coiled Cord Connection Failure
20/03/2023 -
The coiled cord on some Cardiosave IABPs may fail and cause an unexpected shutdown, interrupting therapy to the patient with no warning.
Heater-Cooler Unit HCU 40
20/03/2023 -
Maquet Cardiopulmonary GmbH determined two trends for complaints regarding the Heater Cooler Unit HCU 40: degraded internal drain hoses and leaking vacuum valves. This recall will inform users, and...
La AEMPS informa de pérdidas de señal prolongadas en las aplicaciones FreeStyle LibreLink y FreeStyle Libre 3
17/03/2023 -
La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha tenido conocimiento, a través de la empresa Abbott Laboratories S.A., España, de que las personas...
Aqure System
17/03/2023 -
Radiometer has become aware that there is a problem relating to the Aqure System (stand alone software system) used in combination with the third party device Lumiradx that may result in patient...
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....
FDA Updates Mammography Regulations to Require Reporting of Breast Density Information and Enhance Facility Oversight
10/03/2023 -
FDA Updates Mammography Regulations to Require Reporting of Breast Density Information and Enhance Facility Oversight
Capiox Fx15 Hollow Fiber Oxygenator With Integrated Arterial Filter
10/03/2023 -
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....
Da Vinci Surgical Systems
10/03/2023 -
An increase in reports in which a loose instrument carriage is observed on the universal side manipulator (usm) or the instrument arm of the Da Vinci X and Xi systems. The loose instrument carriage...
Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health Care Providers
08/03/2023 -
The FDA expanded its evaluation of the potential risk of exposure to toxic compounds when using hemodialysis and peritoneal dialysis systems
Smartperfusion and 2D perfusion
06/03/2023 -
Philips has identified through an internal investigation that Smartperfusion and 2D perfusion have technical issues related to the way the perfusion signal is generated and processed, which may lead...
Monaco
06/03/2023 -
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
Recall start date: March 2, 2023
Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility with HLS Set Advanced – Letter to Health Care Providers
06/03/2023 -
Learn more about the issue with the HLS Set Advanced, background, FDA recommendations and FDA actions
Pommel Walker (Senior, Junior, Mini)
02/03/2023 -
If the walker isn't being used as per original design, (e.g. if the chest pad with stem is omitted or is extended beyond capacity to allow for sufficient holding), and the screw is loose, the Pommel...
Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility with HLS Set Advanced – Letter to Health Care Providers
02/03/2023 -
Learn more about the issue with the HLS Set Advanced, background, FDA recommendations and FDA actions
ACTUALIZACIÓN: Uso del Dispositivo Renuvion/J-Plasma para determinados procedimientos estéticos: Comunicado de seguridad de la FDA
01/03/2023 -
El dispositivo Renuvion/J-Plasma puede utilizarse para otros procedimientos estéticos de la piel
Freestyle Libre 2 App (Android)
27/02/2023 -
Freestyle Libre 2 Application (app) users on the Android 13 Operating System (OS), with alarms enabled, may experience situations of extended bluetooth connection loss which results in persistent...
