Tecnología Médica

Tecnología Médica

ICU Medical Burette Set (Clave, Shut-Off)
17/10/2025 - ICU Medical has identified a lot-specific issue where the burette component of the IV set is missing an internal shutoff valve intended to stop fluid flow. IV gravity burette set products that are...
ANMAT advierte sobre fallas de calidad en ciertos lotes del producto médico "Clamp Umbilical", marca PLASTIMED
17/10/2025 - La Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) informa que el Departamento de Tecnovigilancia del Instituto Nacional de Productos...
Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication
17/10/2025 - FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices; asks for reports of injuries related these devices
Eterna™ Implantable Pulse Generator
17/10/2025 - Abbott is notifying customers of a potential issue affecting Eterna™ spinal cord stimulation (SCS) implantable pulse generators (IPGs), Model 32400. These IPGs may experience a loss of...
Zenition 50
17/10/2025 - Philips has been notified by a supplier about an issue affecting integrated chips used in the image intensifier television (IITV) of the Zenition 50 systems. Due to contamination in the bonding...
IMRIS Systems
13/10/2025 - This recall is being initiated to address a notification received by IMRIS Imaging, Inc. from Siemens regarding the venting paths of IMRIS systems that utilize a 3T siemens magnet (Verio, Skyra)....
Filter Set For Cook K-Mar 5200 Pumps
13/10/2025 - For the device in question and, therefore, what was imported as a Class I device, has now been determined to be a Class II device. As there is no Class II license for this device with Health...
Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed
13/10/2025 - Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller
Precision1 One-Day Contact Lenses
13/10/2025 - Alcon is initiating a medical device recall for lot A8041128 of its Precision1™  Daily Soft Contact Lenses. We have identified the potential for a weak seal in some units within this...