FDA Issues Early Alert on React Health VOCSN Ventilators Over Cable Issue
Unseated internal flow transducer connectors can trigger device reboots and therapy interruptions, prompting updated checkout and handling protocols.
Category: Ventilators
Ventilators
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Ventilators
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Nihon Kohden America Launches NKV-440 Ventilator System
Nihon Kohden America has made its NKV-440 Ventilator System available to a broader range of healthcare providers.
Ventilators
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Hamilton Medical Inc. Recalls Ventilators Due to Critical Software Issue
Hamilton Medical Inc. has issued a Class I recall, the most serious category, for Hamilton-C1, C2, C3, and T1 ventilators due to a critical software glitch that can abruptly halt operation after 91 days without restarting.
Ventilators
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FDA Issues Early Alert on React Health VOCSN Ventilators Over Cable Issue
Unseated internal flow transducer connectors can trigger device reboots and therapy interruptions, prompting updated checkout and handling protocols.
FDA: Philips Ventilator Recall Report Numbers Increasing
The FDA received an additional 6,000 medical device reports January 1, 2023-March 31, 2023, related to PE-PUR foam used in Philips ventilators and other devices recalled in June 2021.
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Draeger Issues Recall Notification for Certain Breathing Circuits
The recall addresses potential risks that glued connections of breathing circuits may loosen either before or during the ventilation process.
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Synapse Biomedical’s Diaphragm Pacing System Gets FDA Premarket Approval
The FDA granted premarket approval of Synapse Biomedical’s NeuRx Diaphragm Pacing System for use in patients with spinal cord injuries.
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Philips Issues New Urgent Medical Device Correction for Ventilators
Philips Respironics issued an Urgent Medical Device Correction Letter regarding a problem for certain ventilators that could harm patients.
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Baxter Issues Medical Device Correction for LIFE2000 Ventilator
Baxter has issued a medical device correction for the Life2000 Ventilation System, citing the potential for patient oxygen desaturation events due to improper use with third-party oxygen concentrators, which may cause patient harm or even death.
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Reworked Philips Ventilators Get Class I Recall for Potential Foam Debris Issues
Philips Respironics recalled certain reworked ventilators for issues related to foam adhesion failure and foam debris.
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Ventilators
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Philips Respironics Ventilators Get New FDA Recall Notice
The FDA is providing additional information to patients, caregivers, and healthcare providers about two recent issues in certain ventilators.
