Percussionaire Corporation recalls Phasitron 5

IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.

On 9/17/2025, correction notices were emailed to customers who were informed of future design update and current instructions for use update, and advised: If adequate exhaled tidal volumes cannot be achieved with the In-Line Valve in place, consider removing the IN-Line Valve from the circuit when IPV therapy is not being delivered or choose a different treatment configuration (e.g., direct to artificial airway). Insufficient exhaled tidal volumes may lead to hypoventilation. At initial placement of the In-Line Valve in the inspiratory limb: (either at the patient wye or on the dry side of the humidifier) Allow the ventilator to complete two or more cycles and adjust settings, if necessary, to compensate for any potential leaks and to ensure exhaled tidal volumes are adequate. At completion of IPV treatment when performed with In-Line Valve: 1) Close pressure relief adjustment valve and turn off IPV device in quick succession. 2) Restore ventilator settings noted before treatment and reassess the patient. 3) Allow the ventilator to complete two or more cycles and adjust settings, if necessary, to ensure exhaled tidal volumes are adequate. Warning: The In-Line Valve should not be used in neonates and infants who are at high risk of cardiopulmonary or neurological compromise due to unrecognized hypoventilation. Customers asked to do the following: 1) Print and post updated instructions for use throughout your facility. 2) Communicate and train primary users of IPV therapy. 3) Review instructional protocols and update as needed to conform to the updated instructions. 4) Re-label current product by placing the sticker provided by firm on each individual In-Line Valve bag in stock below the current product label. Distributors were asked to forward the notice to their customers. Questions can be directed to firm via email at: FSCA@sentec.com

• FDA enforcement recordOfficial FDA database entry for Z-0031-2026
• FDA device classification · BZOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5975The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Percussionaire CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.