Class 2 Device Recall Intrapulmonary Percussive Ventilation, IPV 1

• Date Initiated by Firm: August 18, 2026
• Date Posted: September 28, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3319-2026
• Recall Event ID: 99617
• Product Classification: Device, positive pressure breathing, intermittent - Product Code NHJ
• Product: Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruction Manual
• Code Information: Product Number/UDI-DI: S00065/00849436000679, 00849436000709; P5-UC/00849436000686 In-Line Valve Instruction Manual: P20174 Rev D
• FEI Number: 1000524541
• Recalling Firm/ Manufacturer: Percussionaire Corporation; 130 Mcghee Rd Ste 109; Sandpoint ID 83864-8409
• For Additional Information Contact: Benoit Ellenrieder; 208-263-2549
• Manufacturer 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
• FDA Determined Cause: Device Design
• 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 FSCA@sentec.com. If there are any additional questions related to the updated instructions or other questions, please contact FSCA@sentec.com
• Quantity in Commerce: 61,858
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.