The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through internal testing. The devices are being permanently recalled and the FDA advised customers to stop using the product. The FDA said unauthorized individuals could potentially change device therapy settings or access device data if it is left unattended, which could lead to the life-supporting air delivery function not working as intended.   
 
In addition, the FDA identified Class I recalls of Becton Dickinson Alaris Pump Modules and Balt USA Mega Ballast Distal Access Platforms.  

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The Centers for Disease Control and Prevention Feb. 19 released a report on the low use of COVID-19 antiviral drugs among individuals age 65 and older, a…
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Olympus has expanded a voluntary recall of its ViziShot 2 FLEX Needles due to complaints of device components ejecting or attaching during…
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The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including certain wearable devices) and the…
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The Centers for Disease Control and Prevention Dec. 11 released a report that found last year’s version of the COVID-19 vaccine was 76% effective in preventing…
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The AHA provided recommendations to the Food and Drug Administration Dec. 1 in response to a request for information on the measurement and evaluation of…
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The Food and Drug Administration has identified a Class I recall of Max Mobility/Permobil SpeedControl Dials used with the SmartDrive MX2+ Power Assist Device…