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Z-3325-2026Class II

Percussionaire Corporation

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Percussionaire Corporation
Product type
Device
Status
Ongoing
Report date
2026-10-07
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.
Firm state
ID
Product quantity
419
Initiated by
Voluntary: Firm initiated
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

Product description

Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC

Code / lot info

Product/Catalog Number/UDI-DI: S00009/00849436000358, P5-HC/00849436000525

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →