FDA-Device2026-10-07Class IIMISBRANDING

Percussionaire IPV 1 and Phasitron 5 ventilators need updated anesthetic safety instructions

FALSE CLAIMSNationwide distributionMedical devices

What this means

Percussionaire Corporation has updated instructions for its IPV 1 ventilator and Phasitron 5 breathing circuit to warn against using these devices with volatile anesthetic delivery systems. When used together, the ventilator may alter how anesthetic drugs are delivered, potentially causing deeper or lighter anesthesia than intended, which can lead to serious side effects including irregular heart rate, awareness during anesthesia, or oversedation.

  • Review the updated instruction manual (P20174 Rev D) before using IPV ventilators in any operating room or anesthesia setting.
  • Do not use IPV 1 or Phasitron 5 devices with volatile anesthetic delivery systems.
  • Contact Percussionaire Corporation 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
61,858
Manufactured in
130 Mcghee Rd Ste 109, Sandpoint, ID, United States
Products
Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruction Manual

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3319-2026

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