Tag: Ventilators

FDA announces class 1 recalls for infusion pumps, anesthesia workstation

Editor's Note Reports of spontaneous backup battery failure in Dreager Inc.’s Perseus A500 anesthesia workstation and multiple failures in InfuTronix, LLC’s Nimbus infusion pump systems prompted the FDA to classify manufacturer recalls as class 1, the most serious categorization indicating risk of serious harm or death. According to an April…

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By: Matt Danford
April 26, 2024
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FDA recalls BrightView SPECT systems

Editor's Note The FDA has issued a Class I recall of Philips’ BrightView, BrightView X and BrightView XCT Single Photon Emission Computed Tomography (SPECT) scanners due to a component failure that could result in the system’s detector falling on patients. Philips sent all affected customers an Urgent Medical Device Correction…

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By: Matt Danford
February 15, 2024
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Emerging pathogens widespread in mechanical ventilators

Editor's Note Patients in Maryland hospitals on mechanical ventilators were exposed to two dangerous pathogens, which are becoming growing threats in hospital systems, according to a new report published on October 12 by JAMA Network.  The report analyzed survey data from 51 participating healthcare facilities. The data included 482 patients…

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By: Brita Belli
October 26, 2023
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FDA: Class I recall of Mallinckrodt One-Way Valve, 22F x 22M

Editor's Note The Food and Drug Administration (FDA), on September 12, identified the recall by Mallinckrodt Manufacturing of its One-Way Valve, 22F x 22M, as Class I, the most serious. The recall was issued because the devices are not opening properly, which prevents or reduces the flow of ventilated air…

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By: Judy Mathias
September 13, 2023
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FDA: Class I recall of certain Hamilton ventilators

Editor's Note The Food and Drug Administration (FDA), on August 30, identified the recall by Hamilton Medical of its HAMILTON-C1, C2, C3, and T1 ventilators as Class I, the most serious. The recall was initiated because of software issues that may cause the ventilators to stop without notice. There have…

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By: Judy Mathias
August 31, 2023
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FDA: Class I recall of certain Philips Respironics ventilators

Editor's Note The Food and Drug Administration (FDA), on August 14, identified the recall by Philips Respironics of its Trilogy Evo, Evo 02, EV300, and Evo Universal Ventilators as Class I, the most serious. The recall was initiated after detecting dust and dirt from the environment in the air path…

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By: Judy Mathias
August 15, 2023
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FDA: Class I recall of Draeger Medical’s Oxylog 3000 Plus Emergency and Transport Ventilators

Editor's Note The Food and Drug Administration (FDA), on July 13, identified the recall by Draeger Medical of its Oxylog 3000 Plus Emergency and Transport Ventilators as Class I, the most serious. The recall was initiated because of reports that the ventilator may not automatically switch back to using AC…

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By: Judy Mathias
July 14, 2023
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