Percussionaire IPV-1C and Phasitron 5 ventilators need updated anesthetic safety warning
What this means
The FDA has updated labeling for Percussionaire's IPV-1C and Phasitron 5 intrapulmonary percussive ventilators to warn against use with volatile anesthetic delivery systems. When used together, IPV may interfere with controlled anesthetic delivery, potentially causing unwanted changes in anesthetic depth and serious side effects including irregular heart rate, high brain pressure, or unintended awareness during surgery.
- Review the updated instruction manual (P20045 Rev B) before using IPV devices in anesthesia settings
- Do not combine IPV ventilation with volatile anesthetic delivery systems
- Contact Percussionaire Corporation if you have questions about safe use
The agency's original wording
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3321-2026More Percussionaire recalls
- FDA-Device2026-10-07Percussionaire IPV 1 and Phasitron 5 ventilators need updated anesthetic safety instructions
- FDA-Device2026-10-07Percussionaire Travel Air and Phasitron 5 ventilators need updated anesthetic safety warning
- FDA-Device2026-10-07Percussionaire Impulsator and Phasitron 5 IPV devices need updated anesthetic safety instructions
- FDA-Device2026-10-07Percussionaire P5-TEE In-Line Valve labeling updated for anesthetic delivery safety risk
- FDA-Device2026-10-07Percussionaire IPV-2C and Phasitron 5 ventilators need updated anesthetic safety warning
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