Murilo Freitas – Page 2

Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care

Murilo Freitas - 05:00, 1 de December de 2025126

Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may provide incorrect low glucose readings

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-glucose-monitor-sensor-issue-abbott-diabetes-care

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FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment

Murilo Freitas - 20:04, 30 de November de 2025121

FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment
http://www.fda.gov/news-events/press-announcements/fda-expands-artificial-intelligence-capabilities-agentic-ai-deployment

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Recall Alert: Glycar SA Removes Pericardial Patch

Murilo Freitas - 05:00, 30 de November de 202552

Certain SJM Pericardial Patches from Glycar SA may not meet the required tensile strength specification

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-glycar-sa-removes-pericardial-patch

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Correction Alert: Becton Dickinson Updates Use Instructions for BD Alaris Pump Issue

Murilo Freitas - 05:00, 27 de November de 202580

Dropping or severely jarring Alaris Pumps may damage critical pump components. Do not use dropped or jarred devices until thoroughly inspected and tested

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/correction-alert-becton-dickinson-updates-use-instructions-bd-alaris-pump-issue

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Recall Alert: BALT USA Removes MEGA Ballast Distal Access Platform

Murilo Freitas - 05:00, 25 de November de 202562

Balt USA is removing their Mega Ballast because of the unintended presence of loose hydrophilic coating inside the tube at the tip end

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-balt-usa-removes-mega-ballast-distal-access-platform

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Recall Alert: Baxter Permanently Removes Life2000 Ventilation System

Murilo Freitas - 05:00, 25 de November de 202563

Baxter is permanently removing all Life2000 Ventilation Systems after discovering a cybersecurity issue that may allow unauthorized access to the device

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-baxter-permanently-removes-life2000-ventilation-system

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Recall Alert: Max Mobility/Permobil Removes All SpeedControl Dials Used with SmartDrive MX2+ Power Assist Devices

Murilo Freitas - 05:00, 24 de November de 202550

SpeedControl Dials used with SmartDrive MX2+ Power Assist Devices may be unresponsive to users and fail to stop or start unexpectedly, causing injury

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-max-mobilitypermobil-removes-all-speedcontrol-dials-used-smartdrive-mx2-power-assist

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FDA Approves Gene Therapy for Treatment of Spinal Muscular Atrophy

Murilo Freitas - 22:24, 23 de November de 202550

FDA Approves Gene Therapy for Treatment of Spinal Muscular Atrophy
http://www.fda.gov/news-events/press-announcements/fda-approves-gene-therapy-treatment-spinal-muscular-atrophy

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Early Alert: Large Volume Pump Primary Administration Set Reverse Flow Issue from Fresenius Kabi

Murilo Freitas - 05:00, 23 de November de 202554

Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-large-volume-pump-primary-administration-set-reverse-flow-issue-fresenius-kabi

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Recall Alert: Intersurgical Inc Removes i-View Video Laryngoscope

Murilo Freitas - 05:00, 20 de November de 202556

Intersurgical is recalling the i-View Video Laryngoscope due to the device not turning on, battery liquid leakage and screen going blank.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-intersurgical-inc-removes-i-view-video-laryngoscope