Tag: Ventilators

FDA issues Class I recall for Philips BiPAP ventilators

Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…

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By: Matt Danford
August 5, 2025
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FDA designates Class 1 recalls for craniotomy kit, surgical applicator, ventilators

Editor's Note The US Food and Drug Administration (FDA) has deemed Medline’s recent Craniotomy Kit recall, Integra LifeSciences’ MicroMyst Applicator recall, and Maquet Critical Care’s recent ventilator recall as Class I, the most severe category indicating serious risk of injury or death. As detailed in a July 22 FDA announcement,…

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By: Matt Danford
July 22, 2025
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FDA designates Class 1 recalls for closed suction systems, infant heated wire circuits, pediatric emergency tape

Editor's Note Recent recalls of the Ballard Closed Suction Systems from Avanos Medical Inc., Infant Heated Wire Circuits from AirLife/Vyaire, and Broselow Pediatric Emergency Rainbow Tape from AirLife have been designated as Class 1, the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or…

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By: Matt Danford
July 10, 2025
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New guidelines address critical airway challenges in obese surgical patients

Editor's Note A multidisciplinary expert panel has released the first evidence-based airway management guidelines specific to patients living with obesity. Published June 5 in Anaesthesia, the 43-point framework—developed by the Society of Obesity and Bariatric Anaesthesia (SOBA)—offers perioperative strategies aimed at improving the safety and consistency of care in a…

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By: Matt Danford
June 18, 2025
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FDA announces Class 1 recall for ventilator system

Editor's Note The US Food and Drug Administration (FDA) designated Baxter Healthcare Corporation’s recall of the Life2000 ventilator system as a Class 1, the most severe category indicating serious risk of injury or death.   According to the agency’s February 5 announcement, a failed operation during manufacturing compromised the operation…

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By: Matt Danford
February 6, 2025
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Study links pandemic stress to persistent increases in nursing-sensitive quality indicators

Editor's Note A study analyzing data from the National Database of Nursing Quality Indicators (NDNQI) revealed that nursing-sensitive quality indicators (NSIs) worsened during the COVID-19 pandemic and remain elevated years after the onset of the pandemic, reflecting ongoing challenges in nursing practice. Published in the journal Nursing Research, the findings…

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By: Matt Danford
November 22, 2024
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FDA Class 1 recalls target anesthesia workstations, ambulatory infusion pumps, ventilators

Editor's Note The US Food and Drug Administration (FDA) has designated Class 1 recalls—the most severe category indicating risk of serious injury or death—involving three systems: Atlan anesthesia workstations from Draeger, CADD-Solis ambulatory infusion pumps from Smiths Medical, and Trilogy Evo ventilators from Philips Respironics. FDA issued all three announcements…

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By: Matt Danford
November 20, 2024
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FDA designates Class 1 recalls for infusion pump software, ventilator software

Editor's Note The US Food and Drug Administration (FDA) designated software-related recalls for Fresenius Kabi USA’s Iveni Infusion Systems and Philips Respironics Triology Evo ventilators as class 1, the most severe category indicating serious risk of injury or death. According to FDA’s October 1 announcement, Fresenius recalled the Ivenix Infusion…

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By: Matt Danford
October 2, 2024
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FDA announces Class 1 recalls for laryngoscopes, ventilators

Editor's Note Recalls of certain devices and instruction updates for others prompted the US Food and Drug Administration (FDA) to issue Class 1 recalls—the most severe category indicating risk of serious injury or death—for two groups of products: Medtronic’s McGrath MAC and MAC EMS Video Laryngoscopes and Breas Medical’s Vivo…

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By: Matt Danford
September 6, 2024
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FDA announces Class 1 recall for ventilator adapter assemblies

Editor's Note The US Food and Drug Administration (FDA) designated Baxter’s recall of certain Single Patient Use Circuits and Blue Ventilator Adapter Assemblies as Class 1, the most severe recall category indicating significant risk of injury or death. The Single Patient Use Circuit and Blue Adapter Assembly are patient circuit…

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By: Matt Danford
September 5, 2024
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