Early Alert for Philips Ultrasound System
Philips Ultrasound has alerted users that all Lumify diagnostic ultrasound systems have updated use instructions, according to an FDA Early Alert.
Category: Recalls & Advisories
Recalls & Advisories
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Early Alert for Philips Ultrasound System
Philips Ultrasound has alerted users that all Lumify diagnostic ultrasound systems have updated use instructions, according to an FDA Early Alert.
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FDA Seeks Industry Experts for Advisory Committees
The FDA is recruiting scientific, technical, and consumer voting members to join several federal advisory committees, including its Medical Devices Advisory Committee.
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Early Alert for React Health VOCSN Devices
Ventec Life (React Health) issued updated use instructions and inspection procedures for certain VOCSN ventilator devices, according to an FDA early alert.
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Luna G3 APAP Recalled Due to Firmware Defect
According to an FDA alert, BMC Medical Co Ltd retrospectively reported a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States due to firmware defect.
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FDA Early Alert for Draeger Breathing Circuit
Draeger issued a letter to affected customers recommending certain VentStar Resus Neo hoses be removed from where they are used or sold, according to an FDA early alert.
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Recall for GE Healthcare Patient Monitoring System
GE HealthCare has issued updated use instructions for Portrait Mobile Monitoring Solutions devices operating on certain versions of Portrait Core Services software, according to an FDA alert.
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Early Alert for CooperSurgical Neonatal nCPAP Device
CooperSurgical has issued a letter to affected customers recommending certain ventilators be removed from where they are used or sold, according to a USFDA early alert.
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Early Alert for GE Healthcare Portrait Mobile Monitoring Software
GE HealthCare issued updated use instructions for all Portrait Mobile Monitoring Solutions operating on certain versions of Portrait Core Services software, according to an FDA early alert.
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Medline Recalls Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits
The FDA reports a nationwide recall of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits by Medline Industries.
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Hamilton Medical Recalls Breathing Circuit Set
Hamilton Medical issued a recall for certain coaxial breathing circuit sets used with C1, T-1, and MR1 ventilators, ordering them removed from where they are used or sold, according to an FDA alert.
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Early Alert for Baxter Duo-Vent Solution Sets
Baxter has recommended removal of certain Duo-Vent solution sets used for administration of fluids to the patient’s vascular system.
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FDA Issues Early Alert for Resmed Ventilators
Resmed has recommended corrections to certain Astral 100 and Astral 150 ventilators due to an issue that may result in interrupted therapy.
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HHS Ends COVID-19 Emergency Use Authorizations
HHS secretary Robert F Kennedy, Jr signed determinations to end COVID-19 emergency use authorizations for drugs, biological products, and medical devices because the emergency circumstances no longer exist.
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Saline Nasal Spray Recalled Due to Contamination Risk
Beekeeper’s Naturals issued a voluntary nationwide recall for one lot of its saline nasal spray because of potential microbial contamination, according to an alert from the USFDA.
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FDA: Urgent Correction for Baxter Volara System
Baxter issued an Urgent Medical Device Correction notice for all Volara System patient circuits to be corrected prior to continued use, according to an FDA alert.
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Early Alert for Hamilton Medical Ventilator Breathing Circuit
Hamilton Medical issued updated use instructions for certain coaxial breathing circuit sets used with Hamilton-C1, Hamilton T-1, and Hamilton-MR1 ventilators, according to an FDA alert.
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Early Alert for GE HealthCare Infant Resuscitation Systems
GE HealthCare has issued a letter to affected customers recommending Infant Resuscitation Systems and Warmers with a M1091607-R blender be corrected prior to continued use, according to an FDA alert.
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VOCSN V+Pro Ventilators Recalled by React Health
React Health is removing certain VOCSN V+Pro units due to a potential oxygen leak condition prior to or during ventilation.
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Draeger Expands Corrections for Atlan A350 and A350 XL Anesthesia Workstations
A manufacturing error in the ventilator motor assembly may cause mechanical ventilation to fail before or during use, according to an FDA early alert.
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FDA Outlines Enforcement Priorities for E-cigarettes and Nicotine Pouches
New FDA will not prioritize enforcement against unauthorized vaping and nicotine pouch products that have filed premarket applications.
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CMS/FDA Launch New Pathway to Fast-Track Medicare Access for Medical Devices
The RAPID coverage pathway aims to reduce delays between FDA authorization and Medicare coverage for breakthrough technologies.
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FDA Launches Real-Time Clinical Trial Initiative
The FDA is testing a new framework for monitoring safety signals as trials progress to reduce...
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Philips Issues New Ventilator Correction
Philips has issued a recall for Trilogy ventilators be corrected prior to continued use, according to an FDA alert. The alert includes Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal devices.
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FDA Replaces Adverse Event Reporting Systems
The FDA launched its Adverse Event Monitoring System (AEMS), a new unified platform that allows reports for drugs, biologics, vaccines, cosmetics, and animal food to be displayed in a single streamlined dashboard.
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