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

Company / brand

Percussionaire Corporation

Product

Impulsator, Product Number: S00010, 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: S00010/00849436000389, P5/00849436000501, Instruction Manual: P20047 Rev E

Product quantity

228,277

Voluntary mandated

Voluntary: Firm initiated

City

Sandpoint

State

ID

Country

United States

Event id

99617

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