Percussionaire Corporation: Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Percussionaire Corporation
- Product
- Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual
- Reason / 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
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-08-18
- Code info
- Product Number/UDI-DI: S00055/00849436000242, P5/00849436000501, Instruction Manual: P20106 Rev B
- Product quantity
- 228,596
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Sandpoint
- State
- ID
- Country
- United States
- Event id
- 99617
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