Class IIDeviceOngoing

Percussionaire Corporation

Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual

Reason for recall

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

Details

Recall number: Z-3323-2026
Event ID: 99617
Recall initiated: Aug 18, 2026
Classified: Sep 28, 2026
Reported: Oct 7, 2026
Quantity: 228,277
Distribution: 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.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Sandpoint, ID, United States