Percussionaire Impulsator and Phasitron 5 IPV devices need updated anesthetic safety instructions
What this means
Percussionaire has updated labeling for Impulsator and Phasitron 5 ventilation devices to warn against using them together with volatile anesthetic delivery systems. When used together, these devices may interfere with proper anesthetic delivery, potentially causing unintended changes in anesthetic depth, heart rate, blood pressure, or patient awareness during surgery.
- Review the updated instruction manual (P20047 Rev E) before using these devices with anesthetic systems
- Do not use Impulsator (S00010) or Phasitron 5 (P5) in conjunction with volatile anesthetic delivery systems
- Contact Percussionaire Corporation or your device distributor 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-3323-2026More Percussionaire recalls
- FDA-Device2026-10-07Percussionaire IPV 1 and Phasitron 5 ventilators need updated anesthetic safety instructions
- FDA-Device2026-10-07Percussionaire IPV-1C and Phasitron 5 ventilators need updated anesthetic safety warning
- FDA-Device2026-10-07Percussionaire Travel Air and Phasitron 5 ventilators need updated anesthetic safety warning
- 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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