ECRI Urges Patient Safety for FDA Home Healthcare Initiative
ECRI provided recommendations to the FDA’s Home as a Healthcare Hub initiative, emphasizing patient safety for home-use medical devices.
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Search Results for: recall
Baxter Recalls Life2000 Ventilator for Battery Charging Issue
Baxter is recalling the Life2000 Ventilator System due to potential battery charging dongle failure, which can prevent or hinder charging.
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Hamilton Issues Software Correction for Hamilton-C6 Ventilator
Hamilton Medical issued a software correction for the Hamilton-C6 ventilator due to a failure to restart ventilation in sensor fail mode.
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Top Experts Discuss Medical Device Cybersecurity Standards
Four medical device cybersecurity experts—Leon Lerman, CEO and co-founder of Cynerio; Scott Trevino, senior vice president of cybersecurity at TRIMEDX; Shankar Somasundaram, CEO of Asimily; and Ty Greenhalgh, industry principal of healthcare at Claroty—discuss how their platforms comply with various frameworks, offering real-time monitoring, encryption, and incident response to protect medical devices from emerging threats.
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FDA Classifies Philips, Baxter, and Zoll Ventilator Recalls as Class I
Three major manufacturers—Philips Respironics, Baxter Healthcare, and Zoll Medical—have issued Class I recalls for their ventilators due to critical issues posing a risk of serious injury or death.
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