Percussionaire Corporation recalls VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK

Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.

On 12/23/2024, the firm sent an "Urgent Medical Device Notification" to customers informing them that due to recently becoming aware through one customer complaint that the venturi component transiently stopped oscillating while in use. The patient experienced a slight desaturation (low oxygen). When the Phasitron is stuck, the system continues to deliver pressures and volumes, but with reduced amplitude. The set values return when the venturi resumes oscillation. Customers are instructed to: 1. Please review all inventory for impacted lots referenced in the table below. 2. An enhanced Phasitron pre-use check has been developed to evaluate circuits for this issue which replaces the standard pre-use verification until affected products have been replaced at your facility. Please post the instructions provided in Appendix 2 in all areas of your facility. This enhanced pre-use check is to be completed for each new Phasitron breathing circuit in the lots identified below. 3. If product fails the pre-use check found in Appendix 2, DO NOT USE and dispose per your institutional protocol and contact FSCA@sentec.com for product exchange. 4. If a product malfunction is identified during use, please IMMEDIATELY STOP USE of the device and dispose according to your institutional protocol and contact FSCA@sentec.com for product exchange. 5. Complete and Return Acknowledgement form (see Appendix 1) after reviewing and implementing the requested actions by January 31, 2024. 6. After receipt of replacement product: o Dispose remaining product from affected lots per facility protocol. For any question, email FSCA@sentec.com.

• FDA enforcement recordOfficial FDA database entry for Z-0960-2025
• FDA 510(k) clearance · K905235The device's official FDA premarket clearance record
• FDA device classification · CBKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5895The 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.