FDA-Device2026-10-07Class IIMISBRANDING

Percussionaire IPV HC ventilator updated warning for anesthetic interaction risk

FALSE CLAIMSNationwide distributionMedical devices

What this means

Percussionaire Corporation has updated labeling for its IPV HC ventilator and Phasitron P5-HC device to warn against using them together with volatile anesthetic delivery systems. When used together, IPV may interfere with how anesthetic agents are delivered, potentially causing unpredictable anesthetic depth, heart rate changes, increased brain pressure, or unintended awareness during surgery.

  • If you use an IPV HC ventilator or Phasitron P5-HC in an operating room or anesthesia setting, review the updated labeling before your next procedure.
  • Do not use IPV in conjunction with volatile anesthetic delivery systems.
  • Contact Percussionaire Corporation or your equipment supplier 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
419
Manufactured in
130 Mcghee Rd Ste 109, Sandpoint, ID, United States
Products
Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3325-2026

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