FDA-Device2026-10-07Class IIMISBRANDING

Percussionaire Travel Air and Phasitron 5 ventilators need updated anesthetic safety warning

FALSE CLAIMSNationwide distributionMedical devices

What this means

Percussionaire Corporation has updated labeling for Travel Air and Phasitron 5 ventilators to warn against using them with volatile anesthetic delivery systems. When used together, these devices may interfere with anesthetic control, potentially causing deeper or lighter anesthesia than intended, which can lead to serious heart and blood pressure changes, elevated brain pressure, or unintended awareness during surgery.

  • Read the updated instruction manual (Revision B) before using these devices with anesthetic systems
  • Do not use IPV (intrapulmonary percussive ventilation) in conjunction with volatile anesthetic delivery systems
  • Contact your anesthesia team or Percussionaire if you have questions about safe use
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The agency's original wording
Hazard

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

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.
Affected count
228,596
Manufactured in
130 Mcghee Rd Ste 109, Sandpoint, ID, United States
Products
Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3324-2026

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