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Open, Classified

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

FDA Recall Z-3325-2026 · Posted 2026-09-28

Recalling FirmPercussionaire Corporation
Recall StatusOpen, Classified
Product CodeNHJ
Date Initiated2026-08-18
Product Quantity419

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

Firm Action

On 8/18/2026, correction notices were emailed to customers and distributors who were informed of the following: The following warning will be added to associated Instructions for Use: Warning: Do not use IPV therapy in conjunction with volatile anesthetic delivery systems. The high-frequency percussive flow generated during IPV therapy may alter the controlled delivery of volatile anesthetic agents within the breathing circuit, resulting in unpredictable anesthetic agent concentrations that may result in serious patient harm. Note: Consult the anesthesia healthcare provider before disconnecting from the system if considering delivering IPV directly to the patient's airway. Customers were asked to do the following: 1) Print and post the new warning for applicable IPV devices throughout your facility to ensure adequate distribution of new information to users. 2) Reinforce adherence to the IPV User Guide and IPV Quick Reference Guide instructions, including ensuring communication and training primary users of IPV therapy, specifically those using it in-line with a ventilator, on the instructions and new warning. Distributors were asked to do the following: - Translate (if applicable) and send the Urgent Medical Device Field Safety Notice to affected end customers. -If the Distributor receives the signed acknowledgement letters from affected customers, please forward them and all related communication to [email protected]. If there are any additional questions related to the updated instructions or other questions, please contact [email protected]

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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