Philips Respironics Updates Use Instructions for Certain BiPAP Devices
Updated guidance addresses ventilator inoperative alarm failures that may lead to therapy loss, with 13 injuries and eight deaths reported.
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Baxter’s Life2000 Cyber Recall Draws Attention to FDA’s Focus on Software Safety Risks
A cybersecurity vulnerability that prompted Baxter to recall certain Life2000 ventilators is being seen by some industry experts as part of a broader shift in how the FDA treats software-related risks.
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Philips Alerts Customers to Missed Cardiac Telemetry Notifications
Philips’ cardiac telemetry Monitoring Service Application did not route some ECG events from July 2022 to July 2024 for cardiology review.
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Philips Updates Users About Aerosol Risk for Ventilators
Philips has updated instructions for several ventilators to address aerosol deposits on internal sensors when used with in-line nebulizers.
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GE HealthCare Updates EVair Compressor Recall for Ventilator Use
GE HealthCare has issued an update to the EVair Compressor recall, with testing results confirming safe usage across all patient groups.
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