Recall Z-0960-2025 ยท CBK Ventilator, Continuous, Facility Use
Percussionaire Corporation
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10 The Phasitron breathing circuit kit is intended to be used for conti
| Date | Jan 23, 2025 (initiated Dec 23, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 Phasit |
| Quantity | 4,727 packs/cases |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of AZ, FL, IL, MS, MO, NE, NJ, NY, NC, RI, TX, UT, and WV. The countries of Belgium, Canada, France, Hong Kong, Netherlands, Russia, Switzerland and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905235 | VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS Percussionaire Corp., May 3, 1991 |