TemporaryFDAOngoing
Can cause harm that is usually temporary.
Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
Check the device or its packaging for
Product Number/UDI-DI: S00002-C/00849436000020, 00849436000563, 00849436000570, 00849436000143, 00849436000648; P5/00849436000501; Instruction Manual: P20045 Rev B
- Why
- 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
- Distributed
- 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.
- Company
- Percussionaire Corporation
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3321-2026 · retrieved 28 September 2026
Read the official notice