Tecnología Médica
Mapa TecMedTecnología Médica
Aurora EV-ICD™ MRI SureScan™
14/11/2025 -
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. Through 2-October-2025, six (6) events (delay of 2-17 seconds) were observed among 4,900...
Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment
14/11/2025 -
CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use...
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...
What is a Medical Device Recall?
06/10/2025 -
What is a Medical Device Recall?
Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips
25/09/2025 -
Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used.
Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks Due to a Firmware Error
17/09/2025 -
mo-Vis BVBA is correcting R-net Joysticks due to a firmware error that may cause the wheelchair to ignore the neutral setting and move unexpectedly.
ANMAT prohíbe el uso, la comercialización y la distribución del producto "AirSence 10 CPAP, Resmed, código BUM37217, N° de serie 221511"
16/09/2025 -
ANMAT informa que, mediante la Disposición N° 6778/25, se prohibió el uso, la comercialización y la distribución en todo el...
Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes
15/09/2025 -
DreamStation devices may deliver incorrect therapy due to programming errors. Continued use could cause ineffective treatment or harm.
ANMAT prohíbe el producto “Pulse Oximeter - Fingertip-Imalatçi” de la firma JASON INT'L TRADING HK LIMITED - Hong Kong - Made IN P.R.C
15/09/2025 -
ANMAT informa a la población que, mediante
Medical Devices Directorate Quarterly Performance Report for Q1 2025-26
15/09/2025 -
The Medical Devices Directorate quarterly performance reports provides detailed metrics about the timeliness of pre-market medical devices review process against the performance service...
Medical Devices Directorate Annual Performance Report for 2024-25
15/09/2025 -
The Medical Devices Directorate’s Annual Performance Report provide detailed metrics about the timeliness of pre-market medical devices review process against the performance service...
ANMAT prohíbe el producto “Pulse Oximeter - Fingertip-Imalatçi” de la firma JASON INT'L TRADING HK LIMITED - Hong Kong - Made IN P.R.C
12/09/2025 -
ANMAT informa a la población que, mediante Disposición Nº 6671/25 publicada hoy en el Boletín Oficial, se prohíbe el uso,...
ANMAT prohíbe el producto “Pulse Oximeter - Fingertip-Imalatçi” de la firma JASON INT'L TRADING HK LIMITED - Hong Kong - Made IN P.R.C
11/09/2025 -
ANMAT informa a la población que, mediante Disposición Nº 6671/25 publicada hoy en el Boletín Oficial, se prohíbe el uso,...
Guidance for determining medical device application type [2025-08-29]
11/09/2025 -
This document provides guidance to medical device manufacturers on the different application types listed in the Medical Devices Regulations, including how to determine when medical devices can be...
Ventilator Correction: Hamilton Medical AG Corrects HAMILTON-C6 Due to Risk of Ventilation Interruption from Defective Circuit Board
01/09/2025 -
Hamilton is repairing certain HAMILTON-C6 ventilators to replace a defective circuit board that can interrupt ventilation, risking serious injury or death.
Tandem Diabetes Care Issues Voluntary Medical Device Correction for Select t:slim X2 Insulin Pumps
01/09/2025 -
SAN DIEGO – 7 de agosto de 2025 – Tandem Diabetes Care, Inc. (Nasdaq: TNDM) ha anunciado una corrección voluntaria del dispositivo médico para bombas de insulina t:slim...
Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices - Letter to Health Care Providers
01/09/2025 -
The FDA is reminding the public about the safe use of hyperbaric oxygen therapy devices and is providing recommendations to help reduce potential risks.
Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System Due to Software Possibly Resulting in Pump Becoming Unresponsive
01/09/2025 -
ICU Medical is correcting the Plum Duo infusion system due to pump software issues that may cause the device to become unresponsive.
