VDR4 Phasitron Breathing Circuit Models that contain the… recallZ-0960-2025 · Percussionaire Corporation · initiated Dec 23, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Percussionaire Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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 [email protected] 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 [email protected] 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 [email protected].
Recall details
- Recall number
- Z-0960-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 23, 2024
- Posted by the FDA
- Jan 23, 2025
- Recalling firm
- Percussionaire Corporation
- Quantity
- 4,727 packs/cases
- Product code
- CBK
- FDA submissions
- K905235
- 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.
Product description
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 continuous ventilation intended for controlled ventilation of patients
Code information (models, lots, serial numbers)
-Phasitron Kit, VDR, Single Patient, 5pk Model Number - A50094-D-5PK UDI-DI code: 00849436000259 Lot Codes: WO04294 WO04424 WO04764 WO05070 WO05186 WO05460 WO05685 WO05910 WO06388 WO06576 WO06883 WO07095 WO07196 WO07317 WO07405 WO07450 WO07696 - Control Unit Tester Model Number: A51001 VDR4 Lot Codes: WO04750 WO06701 - VDR W/Swivel T Single Patient Phasitron Model Number: PRT 991 Lot Code: WO04733 - VDR4 Humidification Adapter Kit, Case of 10 Model Number: PRT 992 Lot Code: WO045667 - VDR4 Humidification Kit with Cross Tee, Case of 10 Model Number: PRT 993 Lot Codes: WO04745 WO04832 WO04893 WO04893 WO05309 WO06523 WO07080 WO07283
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Percussionaire A50094-DPercussionaire Corporation · Ventilator, Continuous, Facility Use1 recall4 reports
Other devices under the same FDA submission
6 devices cleared under K905235 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Percussionaire F00007-1Percussionaire Corporation · Ventilator, Continuous, Facility Use1 recall16 reports
- Percussionaire A50605-DPercussionaire Corporation · Ventilator, Continuous, Facility Use1 recall5 reports
- Percussionaire S20020Percussionaire Corporation · Ventilator, Continuous, Facility Use1 recall0 reports
- Percussionaire F00008-1Percussionaire Corporation · Ventilator, Continuous, Facility Use5 reports
- Percussionaire F00038-2Percussionaire Corporation · Ventilator, Continuous, Facility Use3 reports
- Percussionaire F00008-1Percussionaire Corporation · Ventilator, Continuous, Facility Use1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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