Tecnología Médica
Mapa TecMedTecnología Médica
Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support
06/06/2023 -
Impella provides short-term pumping support to the heart. Purge fluid leaks may cause the pump to stop providing necessary therapy for critical patients.
Non-sterile, Single-use Pneumatic Tourniquet Cuffs Conservation Strategies – Letter to Health Care Providers
06/06/2023 -
Read the recommendations for health care facilities and providers due to localized supply constraints of non-sterile, single-use pneumatic tourniquet cuffs.
FDA Roundup: June 2, 2023
05/06/2023 -
FDA Roundup: June 2, 2023
Ogival Interbody Cage, PEEK
02/06/2023 -
Stryker has determined that size 11 (11mm) height peek Ogival Interbody Cage (OIC) was incorrectly laser marked as having a size 10 (10mm) height. Recall start date: May 19, 2023
Allen Advance Chest Support With Pad
02/06/2023 -
Baxter Corporation is issuing an urgent medical device recall for the Allen Advance Chest Support to inform customers of the potential for the device to crack where the chest base and prone...
Alerta 4158 (Tecnovigilância) - Comunicado da empresa Shimadzu do Brasil Comércio Ltda - Aparelho de Raios-X Telecomandado Flexavision (10369010048); RADspeed (10369010053).
02/06/2023 -
A estativa de teto de nome CH200/CH200M, objeto deste recall, consiste em uma coluna telescópica que é presa a trilhos fixados no teto e, nesta coluna, é montado o suporte do...
Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
29/05/2023 -
Medtronic has identified a rare potential for reduced or no-energy output during high voltage therapy in Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy...
Alerta 4153 (Tecnovigilância) - Comunicado da empresa Bard Brasil Indústria e Comércio de Produtos para Saúde Ltda - Magic 3 GO Cateter Urinário Intermitente Feminino (80689090170); Magic3 GO Cateter Urinário Intermitente Sure-Grip (80689090171).
29/05/2023 -
A planta de fabricação da “BD” (Becton Dickinson), que produz os Magic3 Go® Cateter Urinário Intermitente identificou uma não conformidade em que alguns...
FDA Roundup: May 26, 2023
29/05/2023 -
FDA Roundup: May 26, 2023
Philips Patient Information Center
29/05/2023 -
During extended operation of the MX40 with the PIC iX, the DHCP (dynamic host configuration protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon...
Draeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can Restrict Breathing Support
29/05/2023 -
Draeger Seattle PAP Plus and some breathing circuit or anesthesia kits may have parts that loosen or detach, preventing needed breathing support.
FDA Roundup: May 23, 2023
24/05/2023 -
FDA Roundup: May 23, 2023
ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that May Impact Infusion Delivery
23/05/2023 -
Replacement batteries for ICU Medical’s Plum 360, Plum A+ and Plum A+3 large volume infusion pumps may have shorter than expected battery life.
Radspeed Pro X-Ray and CH-200 Ceiling Tube Supports
22/05/2023 -
The ceiling tube support for the above device consists of an x-ray tube support pull-up section and an x-ray tube support section to which an x-ray tube assembly is mounted, and the tube holding...
Alerta 4150 (Tecnovigilância) - Comunicado da empresa Alfa Med Sistemas Médicos Ltda - Oxímetro de Pulso Virto.
22/05/2023 -
A empresa recebeu reclamações de mercado relatando dificuldade na leitura ou leitura imprecisa do parâmetro de oximetria de pacientes pediátricos. A equipe de...
Pushtracker E2 & E3 Utilized With Smartdrive MX2+ Power Assist Device
22/05/2023 -
Through design and development work, Max Mobility has identified a software issue with the application. When multiple processes are running on the watch's central processing unit, the application may...
FDA Roundup: May 19, 2023
22/05/2023 -
FDA Roundup: May 19, 2023
La AEMPS informa sobre el nuevo procedimiento del CNCps para confirmar la validez de los certificados emitidos conforme a MDD
22/05/2023 -
La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) informa del nuevo trámite que establece el Centro Nacional de Certificación de Productos Sanitarios (CNCps)...
Heartsine Pad-Pak
18/05/2023 -
Stryker has determined that the affected pad-paks may be rendered inoperable due to depleted battery cells. As a result, the affected pad-paks could potentially fail to power on the device if needed...
Magnetic Coofloss Water Flosser
18/05/2023 -
Recall being conducted as the device does not have a medical device licence in Canada and due to design flaw.
Recall start date: March 27, 2023
